Posted 16 August 2017
By Sharry Arora
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.
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Categories: Generic drugs, Features, FDA, EMA, Health Canada, MHLW, PMDA, TGA, WHO
Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability