By Sai Chamarthy, Philip Kuehl, and Jayne Hastedt
Since 2000, developers of immediate-release oral drugs have been able to request waivers of in vivo bioequivalence studies based on the Food and Drug Administration’s (FDA’s) Biopharmaceutics Classification System (BCS). Based on the work of University of Michigan professor Gordon Amidon, the BCS has allowed more efficient development and regulatory review of immediate release oral drug products based on in vitro data. The oral BCS was originally published in 1995 and has been revisited several times by Amidon and his team(s): Dahan et al and Amidon et al. For oral products, the BCS approach has provided an effective means to develop high-throughput screening paradigms in early discovery, prioritizing development resources in early development and increasing market access due to generics through the waivers of in vivo bioequivalence studies.
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