Guidance on bioequivalence studies

This section provides recommendations to the applicants, who undertake bioequivalence studies and/or who wish to request a waiver of in vivo bioequivalence studies for immediate release solid oral dosage forms.  Guidance herein explains how the bioequivalence studies should be performed, and when biowaivers can be requested in the context of the WHO Prequalification of Medicines Programme.

Data on bioequivalence provide a bridge between two or more pharmaceutical equivalents when safety and efficacy data are available for one of the products, but not for the other.

For multisource (generic) products bioequivalence studies are necessary to ensure therapeutic equivalence and interchangeability of the products. Bioequivalence can also be demonstrated by comparative clinical studies, pharmacokinetic studies or appropriate in vitro studies.

For further information click:

• Guidelines, related to bioequivalence studies

• Glossary on bioequivalence

• Comparator products

• Biowaiver implementation

• Advice on the design of bioequivalence studies

In case of questions related to bioequivalence or choice of comparator products outside the recommended lists, applicants are encouraged to consult WHO Prequalification of Medicines Programme before starting the respective studies.