ICH M9 Guideline in development on Biopharmaceutics Classification System-based biowaivers: An Industrial Perspective from the IQ Consortium.

In 1995 Amidon et al. published a biopharmaceutics classification system (BCS) that utilized a drug’s solubility and permeability to judge the likely impact of in vitro drug product dissolution properties on in vivo absorption and bioavailability.1 Since that time, many regulatory agencies around the world have adopted guidances on use of BCS-based biowaivers. While the guidances are generally similar, they differ in ways that might affect which products qualify for a biowaiver. For products that are marketed globally, this means that otherwise unnecessary human bioequivalence studies will be performed as they are accepted in any market. These differences lead to significant reductions between the maximum (least restrictive guidance criteria) and minimum (most restrictive guidance criteria) number of possible biowaivers In October 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use began efforts to provide recommendations to harmonize guidances for...