What is a Biowaiver under JFDA Guidelines

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2026-06-30 13:22:20 -

A biowaiver under the Jordan Food and Drug Administration (JFDA) guidelines is a Regulatory approval that allows a pharmaceutical manufacturer to skip in vivo bioequivalence (BE) studies in human volunteers. Instead of testing the drug in humans to prove it performs the same as the innovator (reference) product, the JFDA allows the use of comparative in vitro dissolution testing as an...

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