Bioavailability & Bioequivalence Studies
Bioavailability means the rate and extent to which the active drug substance or therapeutic moiety is absorbed from a pharmaceutical form and becomes available at the site of action. For drugs intended to exhibit a systemic therapeutic effect, bioavailability can be more simply understood as the rate and extent to which a substance or its therapeutic moiety is delivered from a pharmaceutical form into the general circulation. Bioequivalence focus on the release of a drug substance from a drug product and subsequent absorption into systemic circulation. Bioequivalence studies are a surrogate marker for clinical effectiveness and safety data as it would not normally be practical to repeat clinical studies for generic products.
- Invitro bioequivalence
- Bioavailability metrics
- Waiver of invivo bioavailability
- Bioequivalence study protocols
- Genetic phenotyping
- Bioequivalence study design
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