Bioequivalence means that two drugs have the same efficacy, bioavailability and safety. A pharmaceutical manufacturer must demonstrate bioequivalence if changes the formulation of a drug, for example pill to liquid form. It is also the parameter according to which generic drug is compared to a trademark. Studies are needed to demonstrate that a generic drug bioequivalence remains equivalent with respect to trademark using the same active ingredient and despite the possible change of carriers, clinical trials or prior research and development process are not required, lowering the cost of generics.
Dr. Juan Sabater-Tobella
European Specialist in Clinical Chemistry and Laboratory Medicine (EC4)Member of the Pharmacogenomics Research NetworkMember of the International Society of Pharmacogenomics and Outcomes ResearchPresidente de EUGENOMIC®
Last modified: Nov 20, 2018 @ 5:26 pm