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Recently Posted Blogs
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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 […]
Member Activity
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Pharma Live wrote a new post
The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release solid oral dosage forms based on a bio-pharmaceutics classification system (BCS). The guidance provides recommendations to sponsors of investigational new drug...
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Pharma Live wrote a new post
The Food Safety and Standards Authority of India, some time back, had set up a task force to put in place some sort of a regulatory mechanism for special food products like nutraceuticals and food supplements marketed in the...
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Pharma Live wrote a new post
The government of India last January issued a notification entitled Pharmacy Practice Regulations 2015 aimed at enhancing the status and practice of pharmacy profession in the country. These regulations are the first comprehensive changes introduced to the outdated provisions...
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Pharma Live wrote a new post
The Scottish Medicines Consortium has approved seven new medicines for use on NHS Scotland, including the first biologic treatment for ulcerative colitis, which affects around 12,400 people across the country. The SMC has waved through Takeda’s Entyvio for (vedolizumab) as the first...
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Pharma Live wrote a new post
The National Pharmaceutical Pricing Authority (NPPA) has fixed prices of 30 formulation packs, including drugs used to treat various diseases such as tuberculosis, diabetes, asthma and antibiotics. In a statement, drug pricing regulator NPPA said it “has fixed/revised the prices...
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Pharma Live wrote a new post
With only 41 out of top 100 pharmaceutical firms responding to its direction to register for online database, the National Pharmaceutical Pricing Authority (NPPA) has warned of action against the rest of them if they do not comply with...
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Pharma Live wrote a new post
In What Is the Industry Underestimating About An ADC Supply Chain? – Part 1, I spoke with industry experts from Seattle Genetics, Lonza, and Marken about the various challenges an ADC supply chain can present, including longer-than-expected timelines and a...
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Pharma Live wrote a new post
Positive data from two trials of Roche’s ALK inhibitor alectinib in lung cancer will be used to support a regulatory filing later this year, according to the company. The studies involved patients with non-small cell lung cancer (NSCLC) whose tumours...
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Pharma Live wrote a new post
The US FDA is to encourage research in rare diseases through 15 grants totalling more than $19m. The regulator said the grants will support clinical studies involving medical devices, drugs and biological products that relate to diseases that affect fewer...
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Pharma Live wrote a new post
The very mention of orphan drugs is enough to give some pharma accountants the jitters. Chasing a cure for a rare disease is an ethical imperative, but high risk, high-cost rarely looks good on the balance sheet. The sector is...
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Pharma Live wrote a new post
A channel strategy is a plan for guiding decisions about a product’s distribution channel, ie the chain of intermediaries that it passes from its production through to delivery to the end user. While channel strategy is not a ‘routine’...
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Pharma Live wrote a new post
Strides Arcolab Limited has received approval from the United States Food & Drug Administration (FDA) for lamivudine and zidovudine tablets USP, 150 mg/300 mg. According to IMS data, the US market for lamivudine and zidovudine tablets is approximately USD 120...
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Pharma Live wrote a new post
FDA Form 483 Frequently Asked Questions Q: When is an FDA Form 483 issued? A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may...
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Pharma Live wrote a new post
1. How often is the Orange Book updated? Since February 2005, we have been providing daily Electronic Orange Book (EOB) product information for new generic drug approvals. Daily generic updates provide the consumer with the current list of approved generic...
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Pharma Live wrote a new post
1. What is the purpose of Drugs@FDA, and what are its main uses? Drugs@FDA allows you to search for official information about FDA approved innovator and generic drugs andtherapeutic biological products. The main uses of Drugs@FDA are: finding labels for approved drug productsfinding generic...
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Pharma Live wrote a new post
Q1. What DMFs incur fees? Only DMFs that cover the manufacture of an API (Type II API DMFs) for use in a generic drug application incur fees. Specifically, each person that owns a Type II API DMF (DMF holder) that...
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Pharma Live wrote a new post
Government policies that support UK pharmaceutical science and enhance export income are costing the NHS millions and undermine the National Institute for Health and Care Excellence. In an essay published today by the Journal of the Royal Society of...
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Pharma Live wrote a new post
Over the past year, a lot of investor attention has been focused on drugmakers as the industry increases its profitability in the wake of healthcare reform. However, this industry isn’t as easy to understand as some others, particularly given that...
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Pharma Live wrote a new post
On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed rule (80 FR 6802) to amend agency regulations governing Abbreviated New Drug Applications (ANDAs) and 505(b)(2) New Drug Applications (505(b)(2)...
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Pharma Live wrote a new post
The Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG, this being a request for a preliminary ruling from the Patents...
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