Meaning Biowaiver
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Biowaiver


An 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 [..]
Source: dfepharma.com




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