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Bioequivalence Study Protocols

Both bioavailability and bioequivalence focus on the release of a drug substance from its dosage form and subsequent absorption into the systemic circulation.

Bioavailability and Bioequivalence studies are required by regulations to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product.

Several in vivo and in vitro methods are used to measure product quality.

(1) In vivo studies:

a) Oral immediate release drug formulations with systemic action
b) Non-oral and non-parenteral drug formulations designed to act by systemic absorption
c) Fixed-dose combination products with systemic action.

(2) In vitro studies:

a) Different strengths of the drug manufactured by the same manufacturer.

Related Journals of Bioequivalence Study Protocols
International Journal of Biomedical 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, Journal for Clinical Studies, Enliven: Biosimilars and Bioavailablity, Chemical Speciation & Bioavailability, Cardiovascular Pharmacology: Open Access, Biochemistry & Pharmacology: Open Access.

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