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- Analytical Discussion
AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications and treatment outcomes. This is one of the largest such screens of its type to date and will drive understanding of the biological mechanisms underlying these conditions […]
F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of two dissolution profiles. F2 factor In short, two profiles are considered identical when f2=100. An average difference of 10% at all measured time points results in a f2 value of 50. A public standard of f2 value between 50-100 to indicate similarity […]
The FDA cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be […]
Pharmaceutical Technology‘s 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms. Issue topics include: Advances in Tableting Analytical Techniques for Efficient OSD Formulation Improving Pharmaceutical Palatability Improving Efficiency in Hot Melt Extrusion and Spray […]
The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for […]
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment. Register free: www.pharmtech.com/pt/stabilitySponsored by Patheon
This webcast invites all pharmaceutical scientists and formulators from R&D and analytical departments that have an interest in the solubilization of poorly soluble drugs, and in understanding the importance of choosing a proper dissolution method in the solubilization tests to reveal the full potential of the tested solubilization method. Register free www.pharmtech.com/dissolutionSponsored by BASF
Strategies and case studies on Systematic and Efficient Analytical Method Development for A Speedy Clinical Product Development presented by experts at Patheon. Learn how to accelerate your first-in-man studies with a deliberate approach to analytical method development for early stage drug products. Register free www.pharmtech.com/efficientSponsored by Patheon
Recently Posted Blogs
- All
- Analytical Discussion
AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications and treatment outcomes. This is one of the largest such screens of its type to date and will drive understanding of the biological mechanisms underlying these conditions […]
F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of two dissolution profiles. F2 factor In short, two profiles are considered identical when f2=100. An average difference of 10% at all measured time points results in a f2 value of 50. A public standard of f2 value between 50-100 to indicate similarity […]
The FDA cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be […]
Pharmaceutical Technology‘s 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms. Issue topics include: Advances in Tableting Analytical Techniques for Efficient OSD Formulation Improving Pharmaceutical Palatability Improving Efficiency in Hot Melt Extrusion and Spray […]
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B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, announced that it received U.S. Food and Drug Administration (FDA) approval for 500mg Meropenem for Injection USP and Sodium Chloride Injection USP and 1g Meropenem for...
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The European Union’s directive on patients’ rights in cross-border healthcare was seen as a bit of a damp squib when it was first adopted, but its importance is now coming into view, writes Reflector. It is always agreeable when buds...
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Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do some more frequently than others. The more comprehensive and structured the investigation process is, the more effective it will...
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Fixed-dose drug combinations (FDCs) which have not received central regulatory approval are sold in substantial numbers in India — despite concerns over the safety and efficacy of these combinations — according to new research led by Queen Mary University...
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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Q1A – Q1F Stability Testings...
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The factsheet provides information on how organisations can access the Medical Dictionary for Regulatory Activities (MedDRA), as well as work by the ICH MedDRA Management Board to ensure that MedDRA is accessible to all those that need it. The factsheet...
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Aim: To facilitate the development of knowledge, and expertise in the regulations, quality standards and guidelines that govern the quality control of pharmaceuticals. Organised by Malaysian Organisation of Pharmaceutical Industry together with Seer Pharma. Date: 8 – 10 June 2015 Day...
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Aim: To provide an introduction to the requirements of Good Manufacturing Practices for supporting design of facilities, equipment and processes in the pharmaceutical and related industries, and to develop a broad understanding of the scope of Good Engineering Practices...
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Those of us in the competitive and highly regulated pharmaceutical, biotechnology and medical device industries understand the need to balance operational efficiency with regulatory compliance. We must find ways to reduce complexities, eliminate redundancies and streamline operations while staying...
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Parametric Release Defined For the purposes of this paper, parametric release is discussed specifically for drug products terminally sterilized by moist heat. Parametric release can be defined as a sterility assurance release program where demonstrated control of the sterilization process...
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POSTED 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, LLC v. Novartis Vaccines & Diagnostics, Inc., and Novartis’ ability to rely on unexpected results discovered after the filing date...
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ABOUT AUTHORS:Jadhav Santosh*, Mali Audumbar, Bathe Ritesh, Tamboli Ashpak, Sawale JyotiramDepartment of Pharmaceutics, Sahyadri College of Pharmacy, Methwade,Sangola, Solapur, Maharashtra, India.*[email protected] ABSTRACT:This article covers fundamental basics of quality complaint.Complaints show customer dissatisfaction about the quality of a pharmaceutical Product. Complaints...
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ABSTRACTStability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and consistency for new drug and pharmaceutical dosage form. The brief understanding of these guidelines can be easily recognized by this...
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ABOUT AUTHORS:Vikash Kumar Chaudhari1*, Vijay Yadav2, Praveen Kumar Verma1, Amit Kumar Singh21Department of Pharmaceutical Chemistry,2Department of Pharmacognosy,Kunwar Haribansh Singh College of Pharmacy, Jaunpur, U.P.*[email protected] ABSTRACTGood manufacturing practices (GMP) is a part of quality assurance which ensures that products are consistently...
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About Authors:Yogeshkumar B. Viradiya*, Manoj B. Dagwar, Swapnil T. LanjewarInstitute of Management Sciences and Research (IMSR),Nagpur, [email protected] Abstract:European Union is the big market for pharmaceuticals. Every pharmaceutical company wants to starts their business in European Union. In European Union come...
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About Author:Yogeshkumar B. ViradiyaDepartment of Regulatory Affairs, Institute of Management Sciences and Research (IMSR),Nagpur, [email protected] Abstract:Regulatory affair is the very important department in Pharmaceutical Company. For the protection of public health, government of various countries have developed the regulation for...
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About Authors:*Parasiya Sachin kumar R., Balamuralidhara V., Pramod Kumar T.M., Rohit Gujarati, Abhisek Shukla, Vandana KshatriPharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics,JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India*[email protected] AbstractAcross Asia, a convergence of economic trends, government...
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About Authors:Abhisek Shukla*, Dr. Valluru RaviPharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics,JSS College of Pharmacy, JSS University,Sri Shivarathreeshwara Nagar, Mysore-570015, Karnataka, [email protected] AbstractA regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known...
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