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Nov
14
ragupathyrenganathan
Dr. Kinam Park, “30 Years of Research on Drug Delivery: A Personal Reflection”
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Nov
14
ragupathyrenganathan
BCS-Based biowaivers: Which drugs are eligible?
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Title: BCS-Based biowaivers: Which drugs are eligible?
5th World Congress on Bioavailability and Bioequivalance Pharmaceutical R&D Summit
September 29-October 01, 2014 Baltimore, USA

Interchangeability of pharmaceutically equivalent multisource drug products can be evaluated by bioequivalence studies. Generally pharmacokinetic, pharmacodynamic or clinical studies involving human subjects are used for bioequivalence evaluation. However, improved understanding of the biopharmaceutical and clinical parameters of drug products has helped pharmaceutical scientists to utilize in vitro dissolution testing as a method to evaluate bioequivalence in lieu of in vivo bioequivalence studies. The term “biowaiver” is used to describe the use of surrogate in vitro method to waive the need for in vivo assessment. The concept of biowaiver is based on the Biopharmaceutics Classification System (BCS) and evaluates the biopharmaceutical and clinical parameters of the active pharmaceutical ingredient and the drug product along with the risks associated with the decision of bioequivalence based on in vitro method. Biowaiver approach provides the advantage of circumventing expensive and time consuming in vivo human studies thus reducing the time to bring multisource drug product into the market.

Anita Nair is a Pharmacist and has a Masters degree from the University of Mumbai, India. She completed her PhD in Pharmaceutical Technology from Goethe University, Frankfurt where she worked extensively on biowaiver concept of drug products and published several biowaiver monographs. She is presently heading the solubility and physico-chemical characterization department at Merck in Germany

Nov
14
ragupathyrenganathan
Strategies for establishing equivalence of complex drug products.
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Title: Strategies for establishing equivalence of complex drug products.
Presenter: Sid Bhoopathy
5th World Congress on Bioavailability and Bioequivalance Pharmaceutical R&D Summit
September 29-October 01, 2014 Baltimore , USA

Nov
14
ragupathyrenganathan
5th World Congress on Bioavailability and Bioequivalance Pharmaceutical R&D Summit 2014
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Title: Novel approach to enhance oral bioavailability of drugs with poor permeability
Author: michael ZhuoWang
5th World Congress on Bioavailability and Bioequivalance Pharmaceutical R&D Summit
September 29-October 01, 2014 Baltimore , USA

Nov
14
ragupathyrenganathan
Drug Delivery and Formulation Summit 2015: Innovation & Technology
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Nov
14
ragupathyrenganathan
Global Drug Delivery & Formulation Summit 2015: The Highlights
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Jul
7
sandeepsd
BBC News ‘Obamacare’ boost to Indian pharmaceutical industry
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Jul
7
sandeepsd
Pharmaceutical Marketing That Works: Marketing Mix
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Jun
15
sandeepsd
FDA and Pharmaceutical Industry
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Discussion of FDA and the pharmaceutical industry

Jun
15
sandeepsd
Dry Granulation and Roller Compaction Technology – YouTube
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This webinar covers different technologies available for granulation and compaction applications in the pharmaceutical industries.