Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution

Abstract

Article history: Received on: 30/10/2015 Revised on: 19/01/2016 Accepted on: 16/02/2016 Available online: 30/04/2016 In the last one decade, due to expiry of patented products as well as their exclusivity period, a drastic decline of branded pharmaceutical products and up streaming of generic drug market has been observed in developed as well as developing… (More)

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