Short Course/Workshop 1- Managing the Life Cycle of a Bioanalytical Method

ABSTRACT

This presentation will focus on the issues that we run into when a method moves through the drug development process from R&D to clinical study support. In the Pharmaceutical industry, most analytical laboratories develop the methods, if these methods are used in regulated clinical studies, they need to be validated and then the studies have to be supported usually at a third party vendor.  The assays have to be robust, the reagents have to be available and there are challenges that we face when we transfer these methods to third party vendors.  This presentation will have case studies that represent multiple factors that may affect the life cycle management of a method.

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