Bioequivalence and Bioavailability Forum

A vast majority² of the attendees preferred applying scaling procedures also to AUC, obviously supporting the concept that HVDs need to have a broad therapeutic range. Application of widening to AUC would be a major step towards increasing the concordance rate among US-FDA, HC and EMA. The majority of meeting participants think that the regulatory agencies should give a clear recommendation on the method to be used for BE evaluation of HVD products. Some participants suggested that recommendations on the scaling method and the PK parameters for which scaling should be allowed may be included in product-specific guidances (PSGs). This proposal would allow for a scientifically based BE approach considering the pharmacological aspects of a certain drug or drug class and the clinical relevance of the endpoint.

1. Mehta M, Schug B, Blume HH, Beuerle G, Jiang W, Koenig J, Paixão P, Tampal N, Tsang Y-C, Walstab J, Wedemeyer R, Welink J. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the fifth international EUFEPS/AAPS conference. Europ. J. Pharm. Sci. 15 August 2023. doi:10.1016/j.ejps.2023.106566. Open access PDF.
   
2. According to the supplementary material 84%.