Upgrading Pharmaceutical Test Methods Using A Contract Research Organization

Methods validation guidelines are becoming more standardized across regulatory jurisdictions. With the adoption of the International Conference on Harmonization's (ICH) guidelines, test methods for mature drugs must be validated to current regulatory standards. This article discusses how a sponsor company can select and partner with a CRO to evaluate, redevelop, and revalidate the analytical test methods used for its mature drug substances and drug products. PDF format.