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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 […]
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The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. “Health care antiseptics are...
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Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products. One final guidance addresses the agency’s overall approach for all...
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Pharma Live wrote a new post
The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. Quality-by-design is a...
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Pharma Live wrote a new post
The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other’s territories. The initiative, starting in January 2012, will enable the two...
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Pharma Live wrote a new post
Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of tools can help to investigate the root cause so that corrective and preventive actions can be effectively implemented. FDA’s Quality System...
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