ABSTRACT
In this chapter, the U.S. Food and Drug Administration (U.S.-FDA) approval process for generic topical dermatological drug products is discussed. The approval of drug products is governed by regulations and guidances that facilitate the development of bioequivalent drug products. The goal is for these generic products to be pharmaceutically and therapeutically equivalent to the reference-listed drug product. The dosage form and indication of the drug product is a signi‘cant determining factor as to which scienti‘c/clinical method, such as waivers of in vivo studies, in vivo pharmacokinetic studies, in vivo pharmacodynamic studies, bioequivalence trials with clinical endpoints, and/or in vitro studies, is the most suitable to demonstrate bioequivalence for a particular topical dermatological drug product. Also discussed in this chapter are some of the previous and current studies of scienti‘c and/or clinical methods that provide the current basis for the U.S.-FDA recommendations.
