Meeting Report: International Workshop on Implementation of Biowaivers Based on the Biopharmaceutics Classification System (BCS)

Does GastroPlus Support Similarity and Dissimilarity Factors of in vitro-in vivo Prediction in Biowaiver Studies? A Lower Strength Amlodipine As a Model Drug

“…dissolution with similarity factors are enough proof of similarity if the drug has a wide therapeutic index and the formulation contained non-interfering excipients [3,5]. The Focus Group on BCS and biowaivers of the International Pharmaceutical Federation (FIP) has invited scientists around the world to prepare biowaiver monographs evaluating the suitability of waiving in vivo BE studies for drugs listed on the WHO's essential medicines list [7,8].…”