Given the rapid progress of the global generics drug market, organisations must critically manage and assess bioequivalence studies that are mandatory when bringing new generic drugs to the market. Most pharmaceutical companies outsource these pivotal bioequivalence studies to CROs in order to expedite the generic drug registration, and the majority outsource facets of these studies to less-regulated regions. Parasiya Sachinkumar, V. Balamuralidhara, and T. M. Pramod Kumar of the JSS College of Pharmacy consider the critical factors associated with outsourcing any clinical or BE study to semi-regulated or emerging markets.
http://jforcs.com/jcs/wp-content/uploads/2014/04/Prospects-of-Conducting-Bioavailability-Bioequivalence-BA-BE-Studies-and-Outsourcing-in-Semi-Regulated-Countries.pdf