Waiving An In Vivo Bioequivalence Study

To date, comparison of the PKs of the drug in plasma to demonstrate BE is considered as the most commonly used and successful tool of similarity of two drug products in terms of safety and efficacy. However, since the initial proposal of the Biopharmaceutics Classification System (BCS) in 1995 (84), regulatory authorities worldwide may accept BE of two drug products based on in vitro data only (29,85) (Table 1), whereas there are ongoing discussions on defining additional situations where in vivo BE studies can be safely replaced with in vitro experiments. Compared with in vivo BE studies, in vitro studies are cheaper, faster, and not associated with ethical considerations. In addition, they provide a better opportunity for focusing at product performance, i.e., at the presentation of the drug to the intestinal epithelium.

Table 1 The Biopharmaceutics Classification System Arranges Drug Substances into Four Classes on the Basis of Their Biopharmaceutical Properties and Provides the Basis for Waving In Vivo BE Studies
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