1 |
BiowaiverAn exemption from the need to perform a clinical bioequivalence study under certain circumstances. Biowaivers are possible in the USA, in Europe and in Japan, but the requirements for achieving a biowaiver differ in these countries. In the USA and Europe the biowaiver is potentially available for rapidly dissolving formulations of BCS class 1 drugs [..]
|
<< Active Pharmaceutical Ingredient | Bradford's method >> |