Tag: FDA bioequivalence

In Vivo vs In Vitro Bioequivalence Testing: When Each Is Used

In Vivo vs In Vitro Bioequivalence Testing: When Each Is Used

In vivo and in vitro bioequivalence testing are two methods used to prove generic drugs work like the brand-name version. Learn when each is required, how they differ, and why regulators choose one over the other.

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Generic Drug Absorption Rates: What the 80-125% Rule Really Means

Generic Drug Absorption Rates: What the 80-125% Rule Really Means

The 80-125% rule for generic drugs isn't about ingredient amounts - it's a strict statistical measure of how well your body absorbs the drug. Learn how this FDA standard ensures generics work just like brand-name drugs.

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