Biowaiver Monograph 2004-2012
Regulations on biowaivers already existed at that time, according to which an in vitro instead of an in vivo assessment could be used to assess bioequivalence for a new tablet or capsule, or a new formulation of an existing immediate release dosage form. On the basis of the in vitro assessment, a new drug product could be considered bioequivalent to its reference product, without having to perform a pharmacokinetic study in human volunteers. To generally describe the use of an in vitro assessment to waive the need for in vivo (bio) studies, the term biowaiver was coined. As this term was originally applied to waiving in vivo studies for registration of lower dosage strengths of drug products, the more precise term "BCS based biowaiver" is sometimes used to distinguish biowaivers based on BCS considerations from biowaivers used for the approval of lower dose strengths of a product.
