Bioequivalence Studies of Solid Oral Dosage Forms Overview
By Sharry Arora -
Published 16 August 2017
The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.
Categories: Features, EMA, FDA, Health Canada, MHLW, PMDA, TGA, WHO, Generic drugs
Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability