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In vitro Bioequivalence

The purpose of bioequivalence studies is to reduce toxicological studies and full-scale clinical trials to prove that the product is of good quality, safe and effective. Bioequivalence studies are typically performed after minor changes of a marketed product or by manufacturers of generic drugs.

A statistical test is proposed for invitro bioequivalence testing between drug products. The proposed test generalizes the one recommended in the FDA 1999 guidance to the situation where replicated observations obtained from each sampled canister or bottle of the drug product are available.

Related Journals of In vitro Bioequivalence
International Research Journal for Inventions in Pharmaceutical Sciences, International Journal of BioAnalytical Methods & BioEquivalence Studies, Journal of Bioequivalence & Bioavailability, MOJ Bioequivalence & Bioavailability, Journal of Molecular Pharmaceutics & Organic Process Research, Bioanalytical Methods & Bioequivalence Studies, Enliven: Biosimilars and Bioavailablity, Journal for Clinical Studies, Chemical Speciation & Bioavailability, Pharmaceutical Regulatory Affairs: Open Access, Journal of Pharmacovigilance.

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