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Nov
14
ragupathyrenganathan
BCS-Based biowaivers: Which drugs are eligible?
Pharma Videos
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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

Jun
16
sandeepsd
A science based approach to topical drug classification system (TCS) – Courtesy of Science Direct
Formulation Discussion, Regulatory Affairs
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The Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products has been very successful; its implementation in drug industry and regulatory approval has shown significant progress. This has been the case primarily because BCS was developed using sound scientific judgment. Following the success of BCS, we have considered the topical drug products for similar classification system based on sound scientific principles. Read more …