BCS Biowaiver

The biopharmaceutical classification system — is it accepted?

The Biopharmaceutical Classification System (BCS), introduced in 1995, provides a framework for classifying the drug substance based on its aqueous solubility and intestinal permeability. It allows for the prediction of in-vivo pharmacokinetics of... more

Jan 31, 2014 2:31 PM Regulatory Affairs Blog