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

Authors: Naser Zaid A, Shraim N, Radwan A, Jaradat N, Hirzallah S, Issa I, Khraim A
Publication: Drug Res (Stuttg)
Keywords: Amlodipine, biowaiver, dissolution, dose strength, IVIVC, product specification, regulatory
Software: GastroPlus®

Background

Many generic pharmaceutical products are currently available on the market place worldwide. Recently, there is a growing concern on the quality and efficacy of generic products. However, health care professionals such as physicians and pharmacists are in difficult situations to choose among alternatives.