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FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics
Pharma Live, , Regulatory Affairs, 0The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety...
FDA issues guidance to support the responsible development of nanotechnology products
Pharma Live, , Regulatory Affairs, 0Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory...
EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications
Pharma Live, , Regulatory Affairs, 0The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint...
European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections
Pharma Live, , Regulatory Affairs, 0The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share...
Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
US FDA issues draft norms on waiver of in-vivo BA & BE studies for subsequent analysis; pharma cos to save time, cost – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release...
Regulation For Nutraceuticals in India – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0The Food Safety and Standards Authority of India, some time back, had set up a task force to put...
Indian Pharmacy Practise Regulations 2015 – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0The government of India last January issued a notification entitled Pharmacy Practice Regulations 2015 aimed at enhancing the status...
Scottish cost regulators OK NHS use of 7 new drugs – Courtesy (Pharma Times)
Pharma Live, , Regulatory Affairs, 0The Scottish Medicines Consortium has approved seven new medicines for use on NHS Scotland, including the first biologic treatment...
Drug Regulator Fixes Prices of 30 Formulation Packs in India – Courtesy (NDTV)
Pharma Live, , Regulatory Affairs, 0The National Pharmaceutical Pricing Authority (NPPA) has fixed prices of 30 formulation packs, including drugs used to treat various...
Drug Firms Warned Over Non-Registration With Online Database in India! – Courtesy (NDTV)
Pharma Live, , Regulatory Affairs, 0With only 41 out of top 100 pharmaceutical firms responding to its direction to register for online database, the...
What Is the Industry Underestimating About An ADC Supply Chain? – Part 2 – Courtesy (pharmaceutical Online)
Pharma Live, , Regulatory Affairs, 0In What Is the Industry Underestimating About An ADC Supply Chain? – Part 1, I spoke with industry experts from...
Roche moves closer to US filing for alectinib – Courtesy(PMLiVe)
Pharma Live, , Regulatory Affairs, 0Positive data from two trials of Roche’s ALK inhibitor alectinib in lung cancer will be used to support a...
The US FDA is to encourage research in rare diseases through 15 grants totalling more than $19m. The regulator...
The moving parts of orphan drug development – Courtesy (PMLiVe)
Pharma Live, , Regulatory Affairs, 0The very mention of orphan drugs is enough to give some pharma accountants the jitters. Chasing a cure for...
A channel strategy is a plan for guiding decisions about a product’s distribution channel, ie the chain of intermediaries...
Strides Arcolab gets US FDA approval for lamivudine & zidovudine tablets for HIV therapy – Courtesy(Pharmabiz)
Pharma Live, , Regulatory Affairs, 0Strides Arcolab Limited has received approval from the United States Food & Drug Administration (FDA) for lamivudine and zidovudine...
FDA Form 483 Frequently Asked Questions Q: When is an FDA Form 483 issued? A: An FDA Form 483 is...
1. How often is the Orange Book updated? Since February 2005, we have been providing daily Electronic Orange Book...
1. What is the purpose of Drugs@FDA, and what are its main uses? Drugs@FDA allows you to search for...
Q1. What DMFs incur fees? Only DMFs that cover the manufacture of an API (Type II API DMFs) for...
Pharmaceutical industry regulation undermines NICE drugs appraisal work – Courtesy (Pharmanews.eu)
Pharma Live, , Regulatory Affairs, 0Government policies that support UK pharmaceutical science and enhance export income are costing the NHS millions and undermine the...
What Is an Abbreviated New Drug Application, And What Does It Mean to Investors?
Pharma Live, , Regulatory Affairs, 0Over the past year, a lot of investor attention has been focused on drugmakers as the industry increases its...
FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations – Courtesy (Hogan Lovells)
Pharma Live, , Regulatory Affairs, 0On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed...
Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions – Courtesy (The SPC Blog)
Pharma Live, , Regulatory Affairs, 0The Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK...
B. Braun Receives FDA Approval to Offer Broad Spectrum Intravenous Antibiotic-Meropenem, in Its Innovative DUPLEX Container – Courtesy (Market Watch)
Pharma Live, , Regulatory Affairs, 0B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, announced that it received U.S. Food...
Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights – Courtesy (pharmaexec.com)
Pharma Live, , Regulatory Affairs, 0The European Union’s directive on patients’ rights in cross-border healthcare was seen as a bit of a damp squib...
CAPA and Root Cause Analysis – Courtesy (Pharmaceutical Manufacturing)
Pharma Live, , Regulatory Affairs, 0Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do...
Many fixed-dose drug combinations in India lack central regulatory approval – Courtesy (EurekAlert)
Pharma Live, , Regulatory Affairs, 0Fixed-dose drug combinations (FDCs) which have not received central regulatory approval are sold in substantial numbers in India —...
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in...
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Aim: To facilitate the development of knowledge, and expertise in the regulations, quality standards and guidelines that govern the...
Aim: To provide an introduction to the requirements of Good Manufacturing Practices for supporting design of facilities, equipment and...
Leveraging Third-Party Audits in Pharma/Biotech Industries – Courtesy (Pharmaceutical Manufacturing)
Pharma Live, , Regulatory Affairs, 0Those of us in the competitive and highly regulated pharmaceutical, biotechnology and medical device industries understand the need to...
Parametric Release Defined For the purposes of this paper, parametric release is discussed specifically for drug products terminally sterilized...
Federal Circuit Says Regulatory Patent Term Extension Prolongs Life of Entire Patent – Courtesy(Pharma Patents)
Pharma Live, , Regulatory Affairs, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 3 NOVEMBER 2011POSTED IN FEDERAL CIRCUIT DECISIONS;PATENT TERM EXTENSIONI wrote previously about the patentability issues raised in Genetics Institute,...
INTRODUCTION ‘Complaint’ is defined as a statement that something is wrong or not good enough. Generally in the pharmaceutical industry, complaints are regarding the quality of drug product. Complaints can be about packaging material, such as ‘the bottle is leaking’, ‘the cap is difficult to open’, ‘the label colour is fading’, ‘one tablet in the blister is missing’ or concerning the product’s aspect and effect, such as ‘there is no effect’, ‘the tablet or solution colour is different’, ‘the tablet is broken’ and so on. Whatever it is about, a complaint shows customer dissatisfaction about a product and, consequently, about a company[1]. Who is the customer? Customers could be internal or external. An internal customer is someone within your company who uses your product or services. And an external customer is an outside organization or individual that receives a product or service from company. If customer dissatisfied with your service, they will complain. Complaint is any communication, written or verbal, received directly from any customer, retailer, distributor, or representative of contract giver, regarding the quality attributes, labelling defects or any other matter such complaints shall be considered as market complaint[2]. Customer complaints are a fact of life in business, and dealing with them is an important part of maintaining customer satisfaction and company reputation. It finds that customer dissatisfaction through two mechanisms: Voice and Exit. If customer makes “Voice” they do complaints. “Exit” occurs when the customer stops using our products or services. To provide better customer service is a way of retaining the customer. Good customer service is important for ensuring that customers are satisfied[2]. “Recall” – A firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. – “Recall” does not include a “market withdrawal” or “stock recovery. “Correction” – The repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. “Market withdrawal” – A firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. “Stock recovery” – A firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm, and no portion of the lot has been released for sale or use[3]. Recall Classification Scheme[3]. • Class I Recall – A situation in which there is a reasonable probability that use of, or exposure to, a violate product will cause serious adverse health consequences or death. • Class II Recall – A situation in which use of, or exposure to, a violate product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. • Class III Recall – A situation in which use of, or exposure to, a violate product is not likely to cause adverse health consequences. Thus, the aim of this article is to discuss the main steps of a good complaint handling procedure that can be readily implemented in pharmaceutical industries. The proposed handling system is in compliance with the GMP Guidelines of EU, USA, Brazil (ANVISA) and is presented in four steps: receiving complaints; technical investigation; corrective and preventive actions (CAPA)/feedback to customers; and monthly reports/trend analysis[1].all of which are represented below and summarized in the Flowchart 1. Classification of Complaints[2]. 1. A-Type Complaints Critical complaints in which product is required to be withdrawn from the market. Such as • Adverse Drug Reaction. • Major health hazard causing permanent deficiency or death. • Purity & Safety. • Potency. • Product Stability 2. B-Type Complaints Major complaints such as • Problem with primary packaging of the product. • b. Chemical / Physical attributes of the product. • c. Extraneous contamination, mix-ups, etc. 3. C-Type Complaints Minor complaints such as a. Problem related to labelling / coding of batch details. b. Shortages. c. Secondary packaging material problem, etc. Responsibility[2]. 1. Production Head 2. Quality Assurance Head 3. Unit Head. STEP 1: RECEIVING COMPLAINTS It is important to have open channels with customers in order to receive their suggestions, doubts and complaints. Generally, these channels are toll-free numbers, e-mails, chat-rooms. Whatever the channel, it is necessary to have a person in charge of receiving the complaints and inputting them into an appropriate investigation form that shall be addressed to the Quality Assurance (QA) unit for investigation. The most flexible channels are toll-free numbers and chat-rooms, since the customer is on-line and the company’s attendee can interview them getting a lot of details. If the complaint was sent by e-mail or to a P.O. box, the recipient must contact the customer by phone and start the interview. The investigation form must include basic information about the complainant, such as: name, address, phone number and e-mail. Information about the product problem is taken, such as: product name, lot number, manufacturing and expiry date, detailed description of complaint, amount of product with problem and any additional information to note. It is important that each opened complaint has a code, e.g. a sequential and unique number, and the receipt date must be recorded [4]. During the customer interview, it is beneficial to briefly outline the complaint handling procedure to the customer, to let him/her know what will be done about the recently received complaint and what kind of feedback will be given to the customer when the investigation is completed. Therefore, the company representative should request that the possibly defective product be sent to the company for further analysis. For the purposes of this article, this product will be called the ‘complaint sample’. It should be documented on the investigation form if the complaint sample will be sent[1]. STEP 2: TECHNICAL INVESTIGATION Upon receipt of the investigation form, the QA unit is able to start the investigation, which can be divided in two phases: documentation-based and laboratory analysis. The documentation-based investigation consists of checking if this complaint occurred previously in the same lot or if any non-conformance was found in the lot during its production that could explain the complaint. The primary documentation to be reviewed in this step consists of the complaint files and the batch records. Complaint files can be consulted to check how many other complaints of the same nature had occurred to a specific lot and how they were handled. Batch records must be verified in order to see if there was any non-conformance during the production that can explain or confirm the quality deviation, and how it was investigated and concluded. The laboratory analysis phase consists of requesting the Quality Control (QC) laboratory to analyse both complaint samples and retained samples – the reserve samples representative of the lot manufactured [5]. This means that, in parallel to the customer sample, which already passed through distribution and third-party holding, the QC laboratory is performing analysis on retained samples, which were kept under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug product was not affected. If the customer did not send the complaint sample for analysis, the laboratory investigation will be carried out only with retained samples. Similar to the receiving step, it is fundamental that the company elects a person in the QA unit to be in charge of technical investigation of each complaint, e.g. a Complaint Officer. This person must have a comprehensive knowledge of the manufacturing process and QC analysis, since they will be responsible for choosing the analytical approach that best fits investigating if the complaint is confirmed or not, and conclude the investigation. This employee is the contact person that links the QA unit to all others, such as Production, Quality Control, Marketing, Finance, Legal and Regulatory Affairs units in order to determine what really happened and what the implications are for both customer and company. Therefore, these responsibilities must be included in the job description of the Complaint Officer. After receiving the analytical results and after performing the documentation-based investigation, the QA unit is able to finish the complaint investigation. There are three possible conclusions, as follows[1]: CONFIRMED COMPLAINT[1]: When both complaint and retained samples showed out-of-specification (OOS) results or when only the complaint sample showed OOS results, but it is clearly a single unexplained failing product. An example of a single unexplained failure may be when one tablet is missing in the intact blister strip in the complaint sample, but no deviation was found in the retained samples or during the in-process controls and final QC analysis recorded in the batch record. But, as a quality problem was identified in the complaint sample, the complaint is classified as confirmed. NON-CONFIRMED COMPLAINT[1]: When both complaint and retained samples showed results in compliance with specifications or when only the complaint sample showed OOS results that cannot be considered a single unexplained failing product. OOS results in a complaint sample can be attributed to misuse or mishandling, when the drug product was not kept under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug product could be affected. An example of a non-confirmed complaint may be when the tablets of the complaint sample show a change in their appearance that is characteristic of a light, humidity or high temperature exposure. This complaint is classified as non-confirmed because the quality problem appeared in the complaint sample due to a product mishandling and cannot be addressed to a manufacturing deviation, since the retained sample, kept under the appropriate conditions of temperature, humidity and light, did not show the same problem. COUNTERFEIT/TAMPER SUSPICION[1]: When the retained sample is within the specification but the complaint sample is clearly OOS with no reason for that, such as a counterfeit or tampered drug product. An example of counterfeit is when packaging material is different from the original; an example of tampering is when the colour of the drug product is completely different from the original or when any foreign substance was added to the product. The Legal Affairs unit and the Competent Authorities must immediately be informed for further arrangements. The Complaint Officer must also check if the complaint represents a serious and unexpected adverse drug experience, which is required to be reported to the health authorities, according to the specific safety reporting regulations of the respective countries. The Complaint Officer must also check if the complaint represents a serious and unexpected adverse drug experience, which is required to be reported to the health authorities, according to the specific safety reporting regulations of the respective countries. The Complaint Officer and the QA Manager must sign off the investigation form once the investigation is completed. The time for concluding a complaint investigation and the retention time of complaint files depend on the regulations of each country; however, 30 days is a reasonable time to conclude an investigation. Complaint files should be retained for at least 1 year after the expiry date of the lot. STEP 3: CORRECTIVE ACTIONS(CAPA) AND FEEDBACKTO CUSTOMERS[1]: For all confirmed complaints, corrective actions must be implemented. These actions can range from a simple and quick training to some employees to a formal Corrective Action and Preventive Action (CAPA) handling. The criteria for choosing appropriate action depends on the nature of the complaint, if the deviation is a single unexplained failing product or not and the complaint incidence. If a CAPA is opened, a multidisciplinary team consisting of representatives of QA, QC, Regulatory Affairs and Production Management must be established. If a quality problem is found in a specific lot, it is important to investigate if the same problem is also present in other lots. Therefore, the company must evaluate if there is a reasonable probability that the use of or exposure to the product with the confirmed quality problem may cause permanent injury, is life-threatening or may lead to death or to a temporary but medically reversible health problem. In these cases, a recall must be triggered. As feedback to the customer, the company must write a response letter to the complainant to explain the investigation approach taken, the results obtained and any implications, in case the quality problem was confirmed. The customer should be sent a free replacement product together with the response letter, since the customer returned the product (the ‘complaint sample’) to the company for analysis and a quality problem was found. STEP 4: MONTHLY REPORTS AND TRENDANALYSIS[1]: Monthly reports should be elaborated in order to evaluate the amount and the nature of the complaints received and to perform a trend analysis of these complaints. The monthly reports must answer the following questions: How many complaints did the company receive in the period? How many were confirmed? How many were non-confirmed or were counterfeit/tamper suspicion? It is also important to know the ‘top 10 products’ which received the majority of complaints, the nature of these complaints, batches involved, the rootcauses of confirmed complaints, how many free offer products were given to customers (to reimburse for the ‘complaint samples’ returned for analysis) and how much the complaint handling cost the company. Another interesting attribute to be monitored is the cycle-time of complaint investigation in order to shorten the feedback time to customers. A controlled copy of the monthly report mustbe delivered to all staff engaged with complaints, as follows: QA, QC, Production Management, Marketing, Finance, Human Resources and Regulatory and Legal Affairs. If the complaint is about any imported product, the original manufacturer must be notified. Some companies also deliver the report to senior management staff. The report must be readily available for Regulatory Agency Inspectors upon request, mainly during GMP inspections. Therefore, these reports can be a major contributor to the Annual Product Review elaboration, since all data concerning complaints is presented monthby- month in these reports. Flow chart 1. The four steps of a complaint handling system.[1] CONCLUSION: Complaints management is a complex problem in a unique industry and the issue promises to remain critical in the future. As a regulatory and market pressures continue to mount upon pharmaceutical companies, industry leaders will need to develop effective solutions or face the high cost inherent in failed technology implementation, FDA censure and weak customer relationship. The preferred alternative is a customer-focused complaints management solution that works. And this present review reveals the various product complaints handlings in the pharmaceutical company for maintaining a good relationship between customer and company. A systematic approach to customer complaints handling increases levels of customer care, levels of customer satisfaction also monitoring of customer care. To get positive benefit from the complaint, it is need to have right procedure to receive, investigate and resolve complaints. Customer complaints are important for a company because they help makethe company better. REFERENCES 1. Glaucia Karime Braga* Complaint Handling in Pharmaceutical CompaniesQual Assur J. Wiley InterScience 2007; 11, 16–21. 2. Shirwadkar BB*, Desai SR, Disouza JI, Systematic Approach for Handling of Customer Complaints Int. J. for Pharm Res. Sch. (IJPRS): 2014, V-3, I-1: 594-98. 3. Neil F. O’Flaherty, Esq. Recall of drug and medical devices: Whats required Whats expected and practical pointers The Legal Background for FDA Medical Device and Drug Recalls 08-15. 4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Good Manufacturing Practices Guide for Active Pharmaceuticals Ingredients-Q7-Chapter 15: Complaints and Recall, 2000. 5. RegulamentoTecnico das Boas Praticaspara a Fabricac¸ao de Medicamentos. AgenciaNacional de Vigilancia Sanitaria, Agosto, 2003.
Pharma Live, , Regulatory Affairs, 0ABOUT AUTHORS:Jadhav Santosh*, Mali Audumbar, Bathe Ritesh, Tamboli Ashpak, Sawale JyotiramDepartment of Pharmaceutics, Sahyadri College of Pharmacy, Methwade,Sangola, Solapur,...
A REVIEW ON STABILITY GUIDELINES BY ICH AND USFDA GUIDELINES FOR NEW FORMULATION AND DOSAGE FORM
Pharma Live, , Regulatory Affairs, 0ABSTRACTStability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and...
A REVIEW ON GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS
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Regulatory Affairs: “Studty Report of New Drug Registration Process in European Union”
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Comparision of NDA procedures & Regulatory structures in Turkey and Canada
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Price regulation in the pharmaceutical industry: Prescription or placebo?
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Reference pricing, competition, and pharmaceutical expenditures: Theory and evidence from a natural experiment
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Do cost-sharing and entry deregulation curb pharmaceutical innovation?
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Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients
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Regulation of pharmaceutical prices: Evidence from a reference pricereform in Denmark
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The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
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Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective☆
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NEW YORK, June 4, 2015 /PRNewswire/ — This report analyzes the worldwide markets for Specialty Enzymes in US$ Million...
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Suven Life Sciences gets patents for neurological drug
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Suven Life’s NCEs for neurodegenerative diseases receive European & Hong Kong patents – Courtesy(Pharmabiz.com)
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Last fall, India’s new Prime Minister, Narendra Modi, met with President Obama in Washington. According to the public accounts,...
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Drug Patents: A New Hedge Fund Target – Courtesy ( Seeking Alpha.com)
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Teva Pharmaceutical (TEVA) Sued By VIVUS, Inc. (VVUS) For Qsymia Patent Infringement – Courtesy(bidnessetc.com)
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Should Vietnam introduce patent term extension? – Coutesy (Lexology)
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Gene Associated with ALS identified ! – Courtesy(Patent Docs)
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Here’s a lucrative idea: Turn a drug into an orphan med, reap 6 months extra exclusivity – Courtesy (Fierce Pharma)
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Frequently Asked Questions on Patents and Exclusivity
Pharma Live, , Intellectual Property Rights, 0What is the difference between patents and exclusivity? Patents and exclusivity work in a similar fashion but are distinctly...
What XML resources are available at the USPTO to process bulk data? Bulk data uses different versions of XML...
How to apply a patent in European Patent Office (EPO) ?
Pharma Live, , Intellectual Property Rights, 0How long does a granted patent stay valid? The maximum term of a European patent is 20 years from...
Senator asks VA to yank patent on Gilead’s Sovaldi to crush its price – Courtesy (Fierce Pharma)
Pharma Live, , Intellectual Property Rights, 0Gilead Sciences ($GILD) has been able to withstand scathing criticism at home over the prices of its hep C...
Brand owners file packaging patents – Courtesy (Packaging Digest)
Pharma Live, , Intellectual Property Rights, 0Wm. Bolthouse Farms, Inc., Bakersfield, CA, inventive container permits point-of-use mixing of separate, compartmentalized ingredients without rupturing the main...
Wyeth denied patent for cancer drug – Courtesy ( The Financial Express)
Pharma Live, , Intellectual Property Rights, 0Wyeth, which was acquired by US- based pharma major Pfizer Inc, has suffered a major setback in India with...
OF ALL the goods and services traded in the market economy, pharmaceuticals are perhaps the most contentious. Though produced...
The Trans-Pacific Partnership And The Costs of Drug Patent Monopolies – Courtesy(OurFuture.org)
Pharma Live, , Intellectual Property Rights, 0The debate over the Trans-Pacific Partnership (TPP) has taken center stage in policy circles in recent weeks. Its proponents...
FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations – Courtesy (Hogan Lovells)
Pharma Live, , Intellectual Property Rights, 0On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed...
No paediatric extension when conditions are not met before SPC expires – Courtesy ( The SPC Blog)
Pharma Live, , Intellectual Property Rights, 0Otsuka Pharmaceuticals Company Limited’s application, 4 March 2015, Dr Lawrence Cullen, for the United Kingdom’s Intellectual Property Office (UKIPO), held...
Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions – Courtesy (The SPC Blog)
Pharma Live, , Intellectual Property Rights, 0The Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK...
Prepare for the Japanese Patent Opposition System Coming Soon – Courtesy (Global IP Matters)
Pharma Live, , Intellectual Property Rights, 0The Japanese Patent Act was revised on May 14, 2014 to provide for post-grant oppositions within one year of the rule...
Maximizing Use of the USPTO’s Patent Application Alert Service
Pharma Live, , Intellectual Property Rights, 0The U.S. Patent and Trademark Office (USPTO) recently launched the Patent Application Alert Service (PAAS), a free electronic tool aimed to...
Helping U.S. Patent Applicants Get Speedy Examination – Courtesy (Global IP Matters)
Pharma Live, , Intellectual Property Rights, 0U.S. patent applicants often have an interest in expediting the patent examination process. The desire to speed examination can...
RCEs and the New USPTO Patent Term Adjustment Rules – Courtesy (Global IP Matters)
Pharma Live, , Intellectual Property Rights, 0On January 9, 2015, the Federal Register published final rules implementing changes to patent term adjustment (PTA) in view of Novartis v....
Court Denies Generic Drug Manufacturer’s Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds
Pharma Live, , Intellectual Property Rights, 0the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District...
Novo Nordisk rejects Baxter patent claim over Novoeight
Pharma Live, , Intellectual Property Rights, 0COPENHAGEN, May 20 (Reuters) – Novo Nordisk said on Wednesday it rejected claims by U.S. rival Baxter International that...
Pfizer Trying To Overcome Patent Cliff – Courtesy (Seeking Alpha)
Pharma Live, , Intellectual Property Rights, 0Pfizer Inc. (NYSE:PFE) is trying to overcome the patent cliff that has seen its recent quarter results suffer by...
Patents Against People: How Drug Companies Price Patients out of Survival – Courtesy (Dissent)
Pharma Live, , Intellectual Property Rights, 0As our television screens toggle between pundits squabbling over Obamacare’s insurance rules and ads for erectile dysfunction remedies, another...
The Nasty Patent Games Drug Companies Play To Stop You From Getting Cheaper Drugs – Courtesy (TechDirt)
Pharma Live, , Intellectual Property Rights, 0The astoundingly wonderful radio program/podcast Radiolab just recently had an episode called“Worth” — which included a few different stories trying...
NOVARTIS spent nearly 15 years seeking a patent in India for Glivec, a medicine for chronic myeloid leukemia. That...
Patent Safe Harbor Applies To Supplemental New Drug Applications
Pharma Live, , Intellectual Property Rights, 0POSTED BY JACOB D. MOORE AND COURTENAY C. BRINCKERHOFF ON 21 MAY 2015POSTED IN FEDERAL CIRCUIT DECISIONS;INFRINGEMENTOn May 13, 2015, the Federal Circuit confirmed...
Federal Circuit Finds No Direct Infringement Of Akamai Patents – Courtesy (Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 19 MAY 2015POSTED IN FEDERAL CIRCUIT DECISIONS;INFRINGEMENTThe Federal Circuit issued its remand decision in Akamai Technologies, Inc....
First Look At False Marking Under The AIA – Courtesy (Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 14 MAY 2015POSTED IN FEDERAL CIRCUIT DECISIONSIn Sukumar v. Nautilus, Inc., the Federal Circuit took its first...
California Supreme Court Scrutinizes Reverse Payment ANDA Settlements – Courtesy (Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 12 MAY 2015POSTED IN ANTITRUSTIn In Re Cipro Cases I & II, the California Supreme Court laid...
Amicus Briefs On Biosimilar Patent Litigation – Courtesy (Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 23 APRIL 2015POSTED IN BIOSIMILARSAmgen has appealed the district court decision denying its motion for a...
Judge Finds Biosimilar Patent Procedures Optional – Courtesy (Pharma Patent)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 23 MARCH 2015POSTED IN BIOSIMILARSJudge Seeborg of the U.S. District Court for the Northern District of...
POSTED BY COURTENAY C. BRINCKERHOFF ON 10 MARCH 2015POSTED IN BIOSIMILARSWhile Sandoz has grabbed the biosimilar headlines for being the first company to have a...
POSTED BY COURTENAY C. BRINCKERHOFF ON 9 FEBRUARY 2012POSTED IN BIOSIMILARSOn February 9, 2012, the FDA issued long-awaited (draft) guidance documents on...
Court Cites Objects Of Invention In Claim Construction – Courtesy (Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 24 FEBRUARY 2015POSTED IN CLAIM CONSTRUCTION;FEDERAL CIRCUIT DECISIONSPacing Technologies, LLC v. Garmin International, Inc. is one of...
Supreme Court Calls For Some Deference In Claim Construction Standard Of Review – Courtesy (Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 22 JANUARY 2015POSTED IN CLAIM CONSTRUCTION;SUPREME COURT DECISIONSOn January 20, 2015, the Supreme Court issued its...
The Importance of Contracts for Joint Infringement in Patent Cases – Courtesy (IP Litigation Current)
Pharma Live, , Intellectual Property Rights, 0POSTED BY JUSTIN M. SOBAJE ON 19 MAY 2015POSTED IN DIVIDED INFRINGEMENT;DIVIDED INFRINGEMENT;PATENTS;PLEADINGS;SUPREME COURTIt has been about a year since the Supreme...
FDA To Give 5 Year NCE Exclusivity To Combinations – Courtesy (Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 26 FEBRUARY 2014POSTED IN FDAIn a Federal Register Notice dated February 24, 2014, the U.S. FDA announced a...
Federal Circuit Finds That FDA Citizen Petition Could Give Rise To Antitrust Liability – Courtesy (Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 7 AUGUST 2014POSTED IN ANTITRUST;FDA;FEDERAL CIRCUIT DECISIONSIn Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the...
Federal Circuit Says Regulatory Patent Term Extension Prolongs Life of Entire Patent – Courtesy(Pharma Patents)
Pharma Live, , Intellectual Property Rights, 0POSTED BY COURTENAY C. BRINCKERHOFF ON 3 NOVEMBER 2011POSTED IN FEDERAL CIRCUIT DECISIONS;PATENT TERM EXTENSIONI wrote previously about the patentability issues raised in Genetics Institute,...
Stem Cells and the Lawsuit That May Shape Our Medical Future – Courtesy (Forbes)
Pharma Live, , Intellectual Property Rights, 0Regenerative Sciences, a medical company that pioneered a procedure to treat orthopedic injuries using patients’ own stem cells, is...
Review on Development of Orphan Drug for Rare disease
Pharma Live, , Intellectual Property Rights, 0ABOUT AUTHORS:Kamshette Sharada*, Poul Bhagwat, Ghodke AmolDepartment of Quality Assurance,Maharashtra College of Pharmacy,Nilanga, Maharashtra, India.*[email protected] ABSTRACTSimply receiving a diagnosis...
Comparing first level patent data with value-added patent information: A case study in the pharmaceutical field q
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0172219008000823-mainDownload
The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0167629610001219-mainDownload
The relationship between a firm’s patent quality and its market value — The case of US pharmaceutical industry
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0040162509000791-mainDownload
A cross-country index of intellectual property rights inpharmaceutical inventions
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0048733314001164-mainDownload
Evergreening, patent challenges, and effective market life in pharmaceuticals
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0167629612000057-mainDownload
The face of the patent is not the ‘‘Whole Story’’: determining effective life of a pharmaceutical patent in the United States
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0172219004000675-mainDownload
To Study The Scope & Importance Of Amended Patent Act On Indian Pharmaceutical Company With Respect To Innovation
Pharma Live, , Intellectual Property Rights, 01-s2-0-s2212567114002469-mainDownload
An exploratory analysis of patent fencing in pharmaceuticals: The case of PDE5 inhibitors
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0048733312002582-mainDownload
To study the problems faced by innover from conception idea to filling patent in Indian pharmaceutical industry
Pharma Live, , Intellectual Property Rights, 01-s2-0-s2212567114002470-mainDownload
Reference pricing, competition, and pharmaceutical expenditures: Theory and evidence from a natural experiment
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0047272710001751-mainDownload
Priority setting for orphan drugs: An international comparison
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0168851010002691-mainDownload
The US Orphan Drug Act: Rare disease research stimulator or commercial opportunity?
Pharma Live, , Intellectual Property Rights, 01-s2-0-s016885100900325x-mainDownload
Evaluating and improving orphan drug regulations in Europe: A Delphi policy study
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0168851012002461-mainDownload
1-s2-0-s1098301512041290-mainDownload
Why orphan drug coverage reimbursement decision-makingneeds patient and public involvement
Pharma Live, , Intellectual Property Rights, 01-s2-0-s0168851015000123-mainDownload
Vanda gets favorable Markman ruling in Fanapt patent infringement litigation
Pharma Live, , Intellectual Property Rights, 0WashingtonSaturday, September 12, 2015, 17:00 Hrs Vanda Pharmaceuticals Inc. (Vanda), a biopharmaceutical company, announced that a favourable Markman ruling...
Locked4Kids is “different by its simplicity,” says Ron Linssen, managing director of Ecobliss Group. The Dutch supplier developed the...
Nasacort OTC package delivers maximum impact with minimal material
Pharma Live, , Pharma Packaging, 0Shelf impact matters more for over-the-counter (OTC) pharmaceuticals than it does for the previous prescription version. So when Nasacort...
How will recent pharma M&As impact packaging departments? – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0The recent wave of mergers and acquisitions among U.S. pharmaceutical companies (Abbvie and Horizon Pharmaceuticals, for example) present implications beyond a...
Deep-drawn aluminum tray protects pharma devices against moisture – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0The new Safemax aluminum container from Constantia Flexibles offers a high level of moisture protection for pharmaceutical devices during their global...
Pfizer to trial thermal imagery for 100-percent seal inspection – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0DIR Technologies, Haifa, Israel, has announced that Pfizer Global Supply will perform a three-month trial of the company’s packaging...
Fusion Packaging unveils innovative foundation bottle – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0Fusion Packaging has unveiled a new and innovative foundation bottle, Scene. Aptly named, the patent-pending package provides a shatterproof,...
FDA approves abuse-deterrent labeling for reformulated OxyContin – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release)...
The new Pharma-Comb label combines features like holograms, color-shifting security inks and guilloche patterns with voiding effects and LaserSecure,...
While many of the conversations in the recently concluded INTERPHEX exhibition hall surrounded more mature, but increasing significant production...
Pharma copackers join forces, boast single-source efficiency – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0Four successful contract packaging and re-packaging companies in the pharmaceutical industry recently joined forces to create a new, single-source...
Pharma packaging needs a dose of improvement – Courtesy (Packaging Digest)
Pharma Live, , Uncategorized, 0Not taking their medications as prescribed, a.k.a. non-adherence, costs Americans dearly. In July 2008, the Journal of Managed Care Pharmacy cited...
PeroXeal is a plastic film with three different functional layers is being used as a new packaging concept for...
Consumers ignore pharma risk warnings – Courtesy(Packaging Digest)
Pharma Live, , Pharma Packaging, 0When it comes to risk disclosures made by drug companies in print and television ads, many consumers are not...
Learn about Changes to USP Packaging Chapters at Pharmapack North America – Courtesy (pmpnews.com)
Pharma Live, , Pharma Packaging, 0Several packaging chapters within the U.S. Pharmacopeia—including some mandatory ones—are now being revised and updated, which could significantly influence...
Sandoz, the generic division of Novartis, announced the opening this month of the Sandoz Packaging Center in Stryków, a...
Child-resistant packaging: One of the noblest assignments -Courtesy ( Healthcare Packaging)
Pharma Live, , Pharma Packaging, 0Child-resistant (C-R) packaging is familiar to most of society; however, it behooves packaging professionals to have more than a...
Diamond-based technology targets drug counterfeiting – Courtesy (Healthcare Packaging)
Pharma Live, , Pharma Packaging, 0Pharmaceutical manufacturers and packaging suppliers have worked for decades to develop processes and materials to combat counterfeits, striving to...
PACK EXPO Welcomes the Center for Trends & Technology Back to Las Vegas – Courtesy (Healthcare Packaging)
Pharma Live, , Pharma Packaging, 0PACK EXPO Las Vegas and Pharma EXPO 2015 (Las Vegas Convention Center; Sept. 28–30) welcome back the Center for...
Pharmaceuticals need an injection of innovation—here’s how – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0Packaging decisions you make matter more now to consumers who are taking healthcare into their own hands—for themselves and for those...
Unlock and harness ‘connected’ pharmaceutical packaging operations – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0Pharmaceutical packaging departments striving for continuous innovation must keep up with healthcare trends, regulatory compliance requirements and the latest...
Weight-loss supplement bottle packs a punch – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0With Thanksgiving behind us and the New Year right around the corner, many of us are looking to slim...
What are the packaging trends and challenges for today’s HBA products? – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0Consumers of health and beauty aids (HBA) expect value and mobility from the packaging, according to a recent survey. Additionally,...
3 tips packaging executives need to know now – Courtesy(Packaging Digest)
Pharma Live, , Pharma Packaging, 0What’s better than a crystal ball in predicting the future? Keen insights from experts in the know that help...
A flurry of container and material patents – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0The first part of 2015 has proven a boom time for the publication of patents for packaging. Perhaps that’s...
Brand owners file packaging patents – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0Wm. Bolthouse Farms, Inc., Bakersfield, CA, inventive container permits point-of-use mixing of separate, compartmentalized ingredients without rupturing the main...
This hot-melt system for case and carton sealing that reduces adhesive costs and boosts packaging production is as notable...
4 benefits of robotic filling take packaging operations to the next level – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0The benefits of this particular filling system design are courtesy of John Henry, Certified Packaging Professional (CPP), owner of...
Smart sensors improve packaging machinery performance – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0Big Data and the industrial Internet of Things can improve the operation of packaging systems, but it all starts...
Sep. 28-30, 2015Las Vegas, NV PACK EXPO Las Vegas will be world’s largest packaging and processing event in 2015....
Anti-aging skincare packaging gets scientific look worldwide – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0Nerium Intl.’s updated packaging design better reflects the science behind its age-defying skincare products and creates a consistent look...
Shelf-stable protein pouch fights malnutrition in Africa – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0new retort pouch lets food processor FasoPro package a local protein source in the African nation of Burkina Faso...
In September 2014, the union health ministry issued a notification banning the use of PET bottles for packaging of...
Nityanand Zadbuke, Sadhana Shahi, Bhushan Gulecha, Abhay Padalkar, and Mahesh ThubeAuthor information ►Article notes ►Copyright and License information ► Abstract The pharmaceutical packaging...
Packaging of pharmaceuticals: still too many dangers but several encouraging initiatives.
Pharma Live, , Pharma Packaging, 0In 2006 in France, several drugs sold in poorly designed packaging exposed patients to a risk of serious adverse...
Why Innovative Drug Delivery Packaging Solutions are needed for Today’s Patients
Pharma Live, , Pharma Packaging, 0Abstract Pressures from consumers, investors, insurance companies, regulators, and governments to drive down costs and improve product performance (efficacy,...
Micro Computer Tomography for medical device and pharmaceutical packaging analysis
Pharma Live, , Pharma Packaging, 01-s2-0-s0731708515000552-mainDownload
A tabu search algorithm for scheduling pharmaceutical packaging operations
Pharma Live, , Pharma Packaging, 01-s2-0-s0377221709003877-mainDownload
One hundred percent online identity check of pharmaceutical products by near-infrared spectroscopy on the packaging line
Pharma Live, , Pharma Packaging, 01-s2-0-s0939641100001260-mainDownload
Analysis of the packaging enclosing a counterfeit pharmaceutical tablet using Raman microscopy and two-dimensional correlation spectroscopy
Pharma Live, , Pharma Packaging, 01-s2-0-s0924203112000720-mainDownload
MWV Healthcare to market Burgopak’s medication adherence packaging in US markets
Pharma Live, , Pharma Packaging, 0MeadWestvaco Corporation (MWV), a global leader in packaging and packaging solutions, announced a licensing agreement with Burgopak Ltd. MWV...
New drug delivery solutions put the patient in control – Courtesy (Packaging Digest)
Pharma Live, , Pharma Packaging, 0As Americans continue to focus on health and wellness, they are taking more control of their healthcare decisions—and they...
Achieving The Perfect Temperature Requirements for Blister Packaging
Pharma Live, , Pharma Packaging, 0By Dr. Egon Huefner, Bürkert Fluid Control Systems When tablets are packaged in blisters, the plastic film must be...
When it comes to meeting quality measures, manufacturers have a variety of standards from the ASTM, FDA and other...
A Guide to Effectively Sourcing and Purchasing Liquid Filling Systems
Pharma Live, , Pharma Packaging, 0There are a few questions to ask yourself when determining which liquid filling machine is right for your project....
Fastening protein-based medical treatments to nanoparticles isn’t easy. With arduous chemistry, scientists can do it. But like a doomed...
Researchers have uncovered a unique connection between diabetes and Alzheimer’s disease, providing further evidence that a disease that robs...
Electronically controlled drugs could minimize side effects
Pharma Live, , Formulation Discussion, 0Potential side effects of many of today’s therapeutic drugs can be downright frightening – just listen carefully to a...
Graphene shows potential as novel anti-cancer therapeutic strategy
Pharma Live, , Formulation Discussion, 0University of Manchester scientists have used graphene to target and neutralise cancer stem cells while not harming other cells....
A new bioprinting method developed at the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Harvard...
A new molecule-making machine could do for chemistry what 3-D printing did for engineering: Make it fast, flexible and...
Generic-Drug-Product-Development-Solid-Oral-Dosage-Forms Concise & informative literature on the various aspects of generic oral solid dosage development
Improved Dissolution Profile of API BCS Class IV Drugs Using Solubility Enhancement Technologies
Pharma Live, , Formulation Discussion, 0PURPOSEThe purpose of the studies was to develop a formulation platform for BCS Class IV API’s, such that the...
Danish researchers at the University of Copenhagen have discovered how to map more than one protein at a time,...
MIT chemical engineers have designed an implantable device that can deliver many drugs at once, allowing researchers to determine...
Pharmaceutical PreFormulation and Formulation The link above is the 2nd edition of the successful series by Mark Gibson; which...
AKRON, Ohio (AP) — Two Ohio graduate students have invented a device that will allow law enforcement officers to...
Danish researchers at the University of Copenhagen have discovered how to map more than one protein at a time,...
Neurons made from human embryonic stem cells can both send and receive nerve impulses when transplanted into the mouse...
How DNA sequencing is transforming the hunt for new drugs
Increasing Manufacturing Efficiencies in Capsule Filling Systems – Courtesy (Pharmaceutical Onine)
Pharma Live, , Formulation Discussion, 0Almost every capsule filling machine on the market is capable of dosing the full range of fill media including...
Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment – Courtesy(PharmTech)
Pharma Live, , Formulation Discussion, 0The pharmaceutical industry has recognized the value of implementing a systematic approach to drug product development where quality is...
Solid Dosage and Excipients 2015 eBook – Courtesy (PharmTech)
Pharma Live, , Formulation Discussion, 0Pharmaceutical Technology‘s 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and...
Tablet compression is a science and an art, and a host of factors contribute to a successful...
Advances in Controlled-Release Drug Delivery – Courtesy(PharmTech)
Pharma Live, , Formulation Discussion, 0The performance of a drug can often be optimized by controlling the rate and extent of its release in...
Injecting Highly Viscous Drugs The author reviews the challenges in delivering macromolecule biologics. – Courtesy (PharmTech)
Pharma Live, , Formulation Discussion, 0It’s been 61 years since Watson and Crick published “A Structure for Deoxyribose Nucleic Acid” in the April 1953...
Solving Poor Solubility with Amorphous Solid Dispersions – Courtesy (PharmTech)
Pharma Live, , Formulation Discussion, 0The oral route remains the most preferred method for delivering drugs. It offers good patient compliance due to its...
Assessing and Improving the Palatability of Pharmaceuticals – Courtesy (PharmTech)
Pharma Live, , Formulation Discussion, 0Taste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments. This article reviews methods...
Surveying the Landscape of Solid-Dosage Manufacturing Experts take a look at the journey travelled thus far and where pharmaceutical...
Particle Engineering for Bioavailability Enhancement – Courtesy (PharmTech)
Pharma Live, , Formulation Discussion, 0Bioavailability enhancement presents one of the most interesting challenges in the way aseptic spray drying projects are approached. With...
PAT has aided formulation, both pre-and post-filing, by reducing costs and time frames. Contrary to popular beliefs, it doesn’t...
Enhancing Dissolution of Poorly Soluble Drugs through Jet-Milling – Courtesy (PharmTech)
Pharma Live, , Formulation Discussion, 0Mechano-chemical activation (MCA) is a process in which mechanical energy is transferred to a solid material during grinding. The...
Spray-dried dispersion technology is a proven approach to improve the dissolution rate and bioavailability of low solubility compounds, and...
Safe and cost-effective capsule filling for pre-clinical and first-in-man studies
Pharma Live, , Formulation Discussion, 0Hear how CoreRx has successfully implemented a flexible automated powder dosing solution for capsule filling, in order to save...
Maximizing Roller Compaction Benefits with Proper Excipient Selection
Pharma Live, , Formulation Discussion, 0The pharmaceutical industry has adopted roller compaction due to its significant advantage in production process efficiency and its applicability...
Lyophilization Cycle Design and Scale Up ̵ Practical Methodologies for Developing Cycles
Pharma Live, , Formulation Discussion, 0Learn how to optimize Lyo Cycle Design and establish robust scale – up methodologies. Register free at www.pharmtech.com/cyclesSponsored by Patheon
EVENT OVERVIEW Current estimates indicate that more than 70% of new chemical entities require solubilization technology to achieve efficacious...
Pharma APIs: It’s Still a Small World – Courtesy (PharmTech)
Pharma Live, , Formulation Discussion, 0A newcomer reading about the pharma industry today might assume that the most, if not the only, interesting work...
Defining the Sterile Barrier of Complex Drug Delivery Systems
Pharma Live, , Formulation Discussion, 0New injection-delivery systems, such as auto-injectors, recombinant syringes, and retractable needles, have introduced new challenges to package validation and...
Solving Tablet-Sticking Problems with I Holland’s Predictive Model
Pharma Live, , Formulation Discussion, 0Tablet sticking is a major problem in tablet manufacture. This build up of granule on the punch tip face...
Allen Institute launches Allen Cell Types Database to make progress in brain research for scientists
Pharma Live, , Formulation Discussion, 0The Allen Institute for Brain Science, an independent nonprofit medical research organization, announced that it is taking the first...
Handbook-of-Pharmaceutical-Excipients_6th_Edition A must have!
Overview: The Best of Pharmaceutical Manufacturing eBook is a collection of the most-read feature articles from 2014, chosen by...
Overview: This paper provides an overview of the continuous processing landscape from dealing with FDA to the intricacies...
CMOs: Pharma’s Heavy Lifters – Courtesy (Pharmaceutcal Manufacturing)
Pharma Live, , Formulation Discussion, 0It’s always exciting to see how a given industry responds to the market’s dynamics, and for pharmaceutical contract services...
Pharmaceutical excipients, a broad array of substances blended with active ingredients into desired finished dosage forms, have, in recent...
FDA Definition– Any adverse event associated with the use of drugs in humans whether or not considered drug related...
Introduction Solid form screening has become an important activity in drug development. The initial screening activity is designed to...
Polymer Strip Films for Delivery of Poorly Water-Soluble Drugs
Pharma Live, , Formulation Discussion, 0Abstract While polymer strip films have garnered significant attention for their patient compliance and cost-effective scale-up, recent studies have...
Drug-Excipient Compatibility for the Formulation Development of Solid Lipid Nanoparticles
Pharma Live, , Formulation Discussion, 0Solid Lipid Nanoparticles Solid lipid nanoparticles (SLN) are a type of a carrier system that employs solid lipids as...
Status Quo, Challenges, and Opportunities of Transdermal Drug Delivery
Pharma Live, , Formulation Discussion, 0Introduction Early work on transdermal drug delivery (TDD) goes back to the 1960s, and in 1971 the seminal US Patent titled...
Major Advances in Oral Drug Delivery over the Past 15 Years
Pharma Live, , Formulation Discussion, 0Introduction The oral route of administration is central for the delivery of a large number of important drugs in...
Introduction Lipinski’s seminal paper on experimental and computational (in silico) methods to estimate the solubility and permeability of drug...
Abstract Lipid formulations, while gaining increasing importance in parenteral and oral drug delivery, are also important in transdermal and...
Investigation of Excipient Compatibility and Associated Degradations for the Formulation Development of a Small Molecule Pharmaceutical Compound
Pharma Live, , Formulation Discussion, 0Introduction Drug formulation starts with the selection of various suitable excipients for the desired or required dosage forms. Drug-excipient interactions can...
Quality by Design (QbD) Approach to Generic Transdermal or Topical Product Development
Pharma Live, , Formulation Discussion, 0Introduction As noted recently, FDA has issued several guidance documents to encourage companies to implement components of Quality by...
Controlled Onset Oral Drug Delivery: An Opportunity for Innovative Life Cycle Management
Pharma Live, , Formulation Discussion, 0Introduction Controlled onset oral drug delivery can be simply described as drug release following a pre-determined time delay; the challenge for...
Commercialising Discovery – Spray drying is the breakthrough technology for the formulation challenges in today’s, modern pharmaceutical business.
Pharma Live, , Formulation Discussion, 0Spray drying is the breakthrough technology that presents R&D technologists with an alternative to remedy some of the formulation...
Cytec Demonstrates Solutions For Solubility Challenges At Innovations In Drug Formulation and Delivery Conference
Pharma Live, , Formulation Discussion, 0May 20, 2015 – Woodland Park, New Jersey – Cytec Industries Inc. (NYSE: CYT) is demonstrating how its docusate...
The blood brain barrier and drug delivery to cns
Laser diffractometry of nanoparticles: frequent pitfalls & overlooked opportunities
Pharma Live, , Formulation Discussion, 0Abstract Laser diffraction is a frequently applied technique for the size analysis of particles. The method possesses many advantages...
Natural bioadhesive biodegradable nanoparticles-based topical ophthalmic formulations for sustained celecoxib release: in vitro study
Pharma Live, , Formulation Discussion, 0Abstract Background: Our goal was to prepare and evaluate topical ophthalmic formulations containing optimized celecoxib-loaded bioadhesive cationic chitosan or anionic...
Testosterone undecanoate – increase of oral bioavailability by nanostructured lipid carriers (NLC)
Pharma Live, , Formulation Discussion, 0Abstract Testosterone undecanoate (TU) has a low oral bioavailability of about 3 % in beagle dogs and 7 %...
Single Core Osmotic Pump (SCOP): Development of Single Layer Osmotic controlled release tablet for poorly soluble drug
Pharma Live, , Formulation Discussion, 0Geeta M. Patel*, Jayendra D. Patel *Corresponding author: Geeta M. Patel [email protected] Author Affiliations : S K Patel Collge of...
Absorption and Drug Development: Solubility, Permeability, and Charge State, 2nd Edition
Pharma Live, , Formulation Discussion, 0With this book as their guide, readers have access to all the current information needed to thoroughly investigate and...
Observations on Nanotechnology-based Drug Delivery Approaches: Translating Nanotechnology from Bench to Pharmaceutical Market: Barriers, Success, and Promises
Pharma Live, , Formulation Discussion, 0David Fairhurst, Ph.D. Robert W. Lee, Ph.D. Particle Sciences, Inc., 3894 Courtney Street, Bethlehem, PA 18017 Introduction To stay...
REVIEW ON APPLICATIONS OF POLYMERS IN PHARMACEUTICAL FORMULATIONS
Pharma Live, , Formulation Discussion, 0About Authors:Darveshwar Jagdeep D*, Mule Madhav S1, Birajdar Shivprasad M2*NRI Institute of Pharmaceutical Science, Bhopal, India1School of Pharmacy, Swami...
NANOPARTICLE (NP) AS A TARGETING DRUG DELIVERY SYSTEM TO BLOOD-BRAIN BARRIER (BBB): A REVIEW
Pharma Live, , Formulation Discussion, 0ABOUT AUTHROS:Bikash Debnath*, Md. JashimUddin, Debasish MaitiState Biotech Hub, Department of Human Physiology,Tripura University, Suryamaninagar.*[email protected] ABSTRACT:Central nervous system (CNS)...
ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF SIMVASTATIN BY TERNARY SOLID DISPERSION TECHNIQUE
Pharma Live, , Formulation Discussion, 0BOUT AUTHORS:Shete Reshma S.1*, Gadhave Manoj V.2, Gaikwad D. D.31Department of Quality Assurance Techniques,2Department of Pharmaceutics,3Department of Pharmaceutics,VJSM’S Vishal...
MOLECULAR MODELING STUDIED FOR INHIBITION OF CALCIUM CHANNEL RECEPTOR: A STRATEGY FOR THE DEVELOPMENT OF NEW ANTIEPILEPTIC DRUG
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:Vinit Raj*, Amit Rai, Deepak Kumar and Vinod KumarDepartment of Pharmaceutical Sciences,Babasaheb Bhimrao Ambedkar University (A Central University),VidyaVihar,...
ABOUT AUTHORS:Abdul Waheed1*, Ankit Gupta2, Parth Patel31Department of Pharmacology2Department of Pharmaceutics3Department of Drug Regulatory AffairAmity Institute of Pharmacy, Amity...
ABOUT AUTHOR:Madhusudan P DabholeGroup Manager – BioProcess,Richcore Life Sciences Ltd, Bangalore, Karnataka, [email protected] ABSTRACTThe scale up of recombinant proteins...
ABOUT AUTHORS:Kalyana Chakravarthi G*, Vijayaraj S, Venugopal A, Naresh Ch, Saritha BDepartment of Pharmaceutical Analysis, Sree Vidyanikethan College of...
ABOUT AUTHOR:Nirlep kaurInstitute of pharmaceutical sciences,Kurukshetra University, Kurukshetra, Haryana, [email protected] ABSTRACTDelivery of drug through Transdermal route represents a most...
ABOUT AUTHORS:V. Sujatha*, T. Vishnuvaravidyadhar, M.Parvathi, Suryaprakash Reddy*Department of Pharmaceutics,Raghavendra Institute of Pharmaceutical Education & Research,RIPERK R Palli Cross,...
A REVIEW ON SINGLE USE DISPOSABLE TECHNOLOGY FOR RECOMBINANT PROTEIN MANUFACTURING
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORMadhusudan P DabholeGroup Manager – BioProcess,Richcore Life Sciences Ltd, Bangalore, Karnataka, [email protected] ABSTRACTThe manufacturing of recombinant products by...
FORMULATION AND EVALUATION OF SOLID LIPID NANOPARTICLES: ISONIAZID
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:Umatiya Imran*, Chintan Aundhia, A.K.Seth, Sachin Chauhan, Nirmal ShahDepartment of pharmacy, Sumandeep Vidhyapeeth University,Piparia, Waghodia, Vadodara, Gujarat, [email protected]...
RESEALED ERYTHROCYTES AS A POTENTIAL DRUG CARRIER: A REVIEW
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:Tapan Behl*, Ishneet Kaur, Rashi Wanchoo Misri, Heena GoelSenior Research Fellow, Department of Pharmacology,Vallbhbhai Patel Chest Institute, University...
ABOUT AUTHORS:Mohalkar Rahul1*, Poul Bhagwat2, Patil S.S1, Shetkar M.A1, Dilip Chavan11 Department of Quality Assurance, Maharashtra College of Pharmacy, Nilanga2 Principal...
ABOUT AUTHORS:Manisha Gahlyan*, Saroj JainHindu college of pharmacyNear Panchayat Bhawan, Gohana Road, Sonepat, [email protected] ABSTRACT:Oral route has been the...
ABOUT AUTHORS:*Abdulrhman. A. Akasha, Malak Ali Elwahedi, Areej Mohmoud EldeebDepartment of Pharmaceutics, Faculty of Pharmacy,Tripoli University, Libya.*[email protected] ABSTRACTCyclodextrins are...
ABOUT AUTHORS:C. Mallikarjuna*1, V. Hari Bhaskar1, Junju. Mohan Kumar2, Rayaprolu. Mounica2, Sai Padmini Bolla21Department of Pharmaceutics, Vagdevi College Of...
Liquid – Solid Technology: An Emerging and advanced technique for Solubilization
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:Imran khan*, M. Idreesh khan, Unis khanDept. of Pharmaceutics in Shri Ram College of pharmacy, Banmore, Morena,Madhya Pradesh,...
About Authors:Fiza Farheen*, Sudhir BharadwajDepartment of Pharmaceutics, Shri Ram College of Pharmacy banmore,Morena (M.P.) [email protected] AbstractOsmotic devices are most...
HISTORY OF CATIONIC VS ANIONIC: IN NASAL DRUG DELIVERY SYSTEM
Pharma Live, , Formulation Discussion, 0ABOOUT AUTHORS:Manu Sharma1, Shikha Chaudhary1, Dharmendra Kumar2*1 R.V.Northland institute, greater Noida, Dadri, UP, India2Brahmanand Group of Institution, 195, Khurja G.T...
BRAIN AS A SANCTURIAN SITE IN DRUG DELIVERY APPROACHES TO IMPROVE BIOAVAILABILITY IN BRAIN
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORSagar Vishwanath Sonawane*Dept. of Pharmaceutical Sciences and Technology,Institute of Chemical Technology,Matunga, Mumbai, Maharashtra, India.*[email protected] ABSTRACTBrain is the highly...
ENGINEERED NANOCARRIERS: AN EMERGING TOOL IN THERAPEUTICS AND DIAGNOSTICS
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:S. Chouhan*, P. Sharma, J. Pathak, A. Namdev, M. SainLachoo Memorial College of Science and Technology,Pharmacy wing; [email protected]...
ABOUT AUTHORS:Meenu Sharma*, Saroj jainDepartment of Pharmaceutics, Hindu college of pharmacyPanchayat Bhawan, Gohana Road, Sonipat (Haryana)[email protected] ABSTRACTAmongst various carriers...
ABOUT AUTHOR:Anjan KhadkaDepartment of Pharmacology,AFMC, Pune, [email protected] ABSTRACT:Interleukins are a subset of a larger group of cellular messenger molecules...
About Authors:Hemant Maheta, MR Patel, KR Patel, MS PatelDepartment of Pharmaceutics,Shri B.M.Shah College of Pharmaceutical Education and Research,College Campus,...
ABOUT AUTHORS:Patel Zinkal K.*, Patel Rahul R, Dr Kanu R Patel, Dr Mukesh R PatelDepartment of Pharmaceutics,Shri B.M. Shah...
ABOUT AUTHORS:Shingitha K.PDepartment of PharmacyNoida Institute Of Engineering And Technology Greater NOIDA, G.B [email protected] ABSTRACTRecently microemulsion have attracted great...
An Insight to In – Situ Gel forming stomach specific drug delivery system
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:Deepak Kumar*, Palak KapoorShoolini University,Solan, Himachal [email protected] ABSTRACT:The oral delivery of drugs having narrow absorption window in the...
Formulation and Characterization of micro-emulsion based gel of Anti fungal drug
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:Harsh Vyas1*, Tulsi Upadhyay1, Nirali Thakkar1, Kruti Patel1, Umesh Upadhyay2,1Students, 2Faculty of pharmacySigma Institute of Pharmacy,Bakrol, Vadodara, Gujarat, India*[email protected], [email protected]...
Nanocochleate – A Novel Bypass of Conventional Drug Delivery System
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:Harsh Vyas1*, Tulsi Upadhyay1, Nirali Thakkar1, Kruti Patel1, Umesh Upadhyay2,1Students, 2Faculty of pharmacySigma Institute of Pharmacy,Bakrol, Vadodara, Gujarat, India*[email protected], [email protected]...
ABOUT AUTHORS:Surya Pratap Singh*, Meenakshi Sahetya1, Mahaveer Prasad khichi1*, Yogesh Yaduwanshi21Department of pharmaceutics, Kota college of pharmacy2Department of pharmacology,...
About Authors:*1Ronak Patel, 2Mr. Ripal Mistry1M.Pharm, Bhupal Nobels’ College Of Pharmacy, Udaipur 3130012M.pharm, Indubhai Patel College Of Phaarmacy And Research...
Powders and Bulk Solids: Behaviour, Characterization, Storage and Flow
Pharma Live, , Formulation Discussion, 0Great ebook by Dietmar Schulze powders and bulk solids Some content on this page was disabled on May 23,...
ABOUT AUTHORS:Edukondalu.Vanka*, M. Jhansi Rani, A.M.Sudhakar Babu, P.Venkatesawara RaoDepartment Of Pharmaceutics,A.M. Reddy Memorial College of Pharmacy,Narasaraopet, Guntur (district), Andhra...
Nanosuspension- A Novel Drug Delivery System via Nose to Brain drug delivery!
Pharma Live, , Formulation Discussion, 0About Authors:N.V. Sateesh Madhav, Abhijeet Ojha, Pallavi Uniyal, Dheeraj Fulara*DIT Faculty of Pharmacy, Mussoorie Diversion Road, Dehradun 248009,Uttarakhand, India.*[email protected]...
Product Life Cycle Management in Pharmaceuticals – A Review
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:S.P.Sethy*, Tahseen Sameena, Prathima Patil, K.ShailajaDepartment Of Pharmaceutical Chemistry.Sushrut Institute of PharmacyTaddanpally (V), Pulkal (M), [email protected] ABSTRACT:The complexity...
ABOUT AUTHOR:Muhammed MujahedMaster’s of Science in Biotechnology.SRTM [email protected] INTRODUCTION:Drug design is an integrated developing discipline which portends an era...
ABOUT AUTHORS:*Sambhara Gayatri Deepti1, Aruna Ragidi1, A.M.S.Sudhakar Babu1, P.Venkateswara Rao21Department of Pharmaceutics2Department of Pharmaceutical AnalysisA.M.Reddy Memorial college of Pharmacy,...
ABOUT AUTHORS:Jyoti MalikHindu College of Pharmacy,Sonepat, [email protected] ABSTRACT:There was a need for delivery systems that could maintain a steady...
Solubility Enhancement of BCS Class 2 Drug by Novel Drug Solution Drop Technique!
Pharma Live, , Formulation Discussion, 0ABOUT AUTHOR:AnilkumarDr.Ambedkar Institute of TechnologyBangalore, [email protected] INTRODUCTIONThe dissolution rate of drug from tablet is affected by its active ingredient’s...
Brain Drug Delivery of Nanoparticles by Nasal Route for the treatment of Depression
Pharma Live, , Formulation Discussion, 0ABOUT AUTHORS:Rakhi Choudhary*, Lakshmi Goswami , Preeti KothiyalShri Guru Ram Rai Institute of Technology & Science P.O. Box –...
About Authors:Deepti Soni*, Rathore KS1, Nema RK2*College of Pharmaceutical Sciences, Behrampur, Orissa1BN Institute of Pharmaceutical Sciences, Udaipur, Raj.2Rishiraj College...
Pharmacosome – A Spanking Accession in Vessicular Drug Delivery System
Pharma Live, , Formulation Discussion, 0About Authors:Swati Yadav1*, Dr. S.K Prajapati11institute of pharmacy,Bundelkhand University, Jhansi*[email protected] Abstract: 11, 12Pharmacosome is a neoteric amelioration in the terrain...
ABOUT AUTHORS:Anup Megotia*, Meenu Nagpal, Upendra K Jain, VarunDept. of Pharmaceutics, Chandigarh College of Pharmacy,Landran, Mohali-160065*[email protected] ABSTRACTWhile rapidly disintegrating...
About Authors:Poonam K*, Saurabh SS, Arpana Kumari, Rathore KS1*Department of Pharmaceutics, Lachoo Memorial College of Science and Technology, Pharmacy...
Rate-dependent mechanical properties of dry blended pharmaceutical powder formulations for tabletting applications
Pharma Live, , Formulation Discussion, 01-s2-0-s0032591010005322-main-1Download
Physical stability of pharmaceutical formulations: solid-state characterization of amorphous dispersions
Pharma Live, , Formulation Discussion, 01-s2-0-s0165993613001386-mainDownload
1-s2-0-s0168365909001254-mainDownload
Prediction of suitable amounts of water in fluidized bed granulation of pharmaceutical formulations using corresponding values of components
Pharma Live, , Formulation Discussion, 01-s2-0-s0378517307008708-mainDownload
Design and quality control of a pharmaceutical formulation containing natural products with antibacterial, antifungal and antioxidant properties
Pharma Live, , Formulation Discussion, 01-s2-0-s0378517309003457-main-1Download
Novel oral formulation approach for poorly water-soluble drug using lipocalin-type prostaglandin D synthase
Pharma Live, , Formulation Discussion, 01-s2-0-s0928098715001554-mainDownload
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
Pharma Live, , Formulation Discussion, 01-s2-0-s0378517311006557-mainDownload
Lipospheres and pro-nano lipospheres for delivery of poorly water soluble compounds
Pharma Live, , Formulation Discussion, 01-s2-0-s0009308412000084-mainDownload
1-s2-0-s135964460302600x-mainDownload
Early pharmaceutical profiling to predict oral drug absorption: Current status and unmet needs
Pharma Live, , Formulation Discussion, 01-s2-0-s0928098713004223-mainDownload
1-s2-0-s1359644603029027-mainDownload
Patient-centered drug discovery as the means to improved R&D productivity
Pharma Live, , Formulation Discussion, 01-s2-0-s1359644615001464-mainDownload
1-s2-0-s0041010114003511-mainDownload
The continuing evolution of the drug discovery process in the pharmaceutical industry
Pharma Live, , Formulation Discussion, 01-s2-0-s0014827x01010199-mainDownload
1-s2-0-s0378517311002419-mainDownload
1-s2-0-s1359644604033161-mainDownload
1-s2-0-s1359644603026497-mainDownload
1-s2-0-s1359644614000816-mainDownload
Modelling of the break force of tablets under diametrical compression – Science Direct
Pharma Live, , Formulation Discussion, 0A numerical method to predict the break force of curved faced tablets is proposed. The constitutive model and the...
Impact of compression pressure on tablet appearance – Science Direct
Pharma Live, , Formulation Discussion, 0The color of model tablets deepened and tablet gloss increased with increase in compression pressure regardless of colorant type....
Predictability of drug release from water-insoluble polymeric matrix tablets – Science Direct
Pharma Live, , Formulation Discussion, 0The purpose of this study was to extend the predictability of an established solution of Fick’s second law of...
The effect of polymer properties on direct compression and drug release from water-insoluble controlled release matrix tablets – Science Direct
Pharma Live, , Formulation Discussion, 0The objective of this study was to identify and evaluate key polymer properties affecting direct compression and drug release...
Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective☆
Pharma Live, , Formulation Discussion, 01-s2-0-s0169409x07003195-mainDownload
Sex, Gender, and Pharmaceutical Politics: From Drug Development to Marketing
Pharma Live, , Formulation Discussion, 01-s2-0-s1550857910000823-mainDownload
A science based approach to topical drug classification system (TCS) – Courtesy of Science Direct
Pharma Live, , Formulation Discussion, 0The Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products has been very successful; its implementation in...
Formulation factors affecting acceptability of oral medicines in children – ScienceDirect
Pharma Live, , Formulation Discussion, 0Acceptability of medicines in children and caregivers affects safety and effectiveness of medicinal treatments. The pharmaceutical industry is required...
Understanding the impact of microcrystalline cellulose physicochemical properties on tabletability – ScienceDirect
Pharma Live, , Formulation Discussion, 0The quality by design (QbD) initiative is promoting a better understanding of excipient performance and the identification of critical...
Formulation of immediate release pellets containing famotidine solid dispersions
Pharma Live, , Formulation Discussion, 01-s2-0-s1319016413000169-mainDownload
Sirolimus solid self-microemulsifying pellets: Formulation development, characterization and bioavailability evaluation
Pharma Live, , Formulation Discussion, 01-s2-0-s0378517312007764-mainDownload
Investigation for the quality factors on the tablets containing medicated pellets
Pharma Live, , Formulation Discussion, 01-s2-0-s131901641500033x-mainDownload
Tanshinone IIA – loaded pellets developed for angina chronotherapy: Deconvolution-based formulation design and optimization, pharmacokinetic and pharmacodynamic evaluation
Pharma Live, , Formulation Discussion, 01-s2-0-s0928098711000108-mainDownload 1-s2-0-s0928098715002080-mainDownload
1-s2-0-s092809870200221x-mainDownload
Site-specific drug delivery systems within the gastro-intestinal tract: From the mouth to the colon
Pharma Live, , Formulation Discussion, 01-s2-0-s0378517310003467-mainDownload
A novel dissolution method for evaluation of polysaccharide based colon specific delivery systems: A suitable alternative to animal sacrifice
Pharma Live, , Formulation Discussion, 01-s2-0-s0928098715001128-mainDownload
Enzyme/pH dual sensitive polymeric nanoparticles for targeted drug delivery to the inflamed colon
Pharma Live, , Formulation Discussion, 01-s2-0-s0927776514004974-mainDownload
AstraZeneca and Montreal Heart Institute to screen 80,000 samples for cardiovascular and diabetes genetic traits – Courtesy (World Pharma News)
Pharma Live, , Analytical Discussion, 0AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of...
Profile Similarity Determination/ F2 – Drug dissolution testing/ Variabilities
Pharma Live, , Analytical Discussion, 0F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of...
New data shows test can help physicians remove patients with suspected TB from isolation earlier
Pharma Live, , Analytical Discussion, 0The FDA cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can...
Solid Dosage and Excipients 2015 eBook – Courtesy (PharmTech)
Pharma Live, , Analytical Discussion, 0Pharmaceutical Technology‘s 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and...
Practical Implementation of the New Elemental Impurities Guidelines
Pharma Live, , Analytical Discussion, 0The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical...