Today all new drugs approved by the FDA and the EMA contain information related to the BCS classification of the molecule and its drug product. Although the purpose of BCS is to characterize drugs for which products of those drugs may be eligible for a biowaiver of in vivo bioequivalence studies, there is no inherent predictability of this characteristic, since the categorization is based on experimental results. Bcs class 4. This simple categorization of drugs into four classes has spawned many further approaches in drug product analysis. BDDCS is one of those derivative approaches.
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