CPSA Shanghai 2011
Changing Paradigm in Drug Discovery & Development:
East Meets West
April 13 - 16, 2011
Renaissance Shanghai Pudong Hotel
Shanghai, China
Abstract
Friday PM - Parallel Session II
Bioanalytical Method Transfer-Opportunities and Challenges
Naidong Weng
Janssen Pharmaceutical Research & Development, LLC, 1000 Route 202 South, Raritan, NJ 08869
With the globalization of drug development, the increased bioanalytical outsourcing from pharmaceutical companies and merge of pharmaceutical companies, method transfer to a different site within a pharmaceutical company or to one or multiple contract research organizations (CROs), especially in the emerging markets, has been dramatically increased in the past several years. Bioanalytical method transfer is an important step before routinely implementing the method at the receiving site for sample analysis. It is clearly stated in the 2001 Food and Drug Administration (FDA) Guidance on Bioanalytical Method Validation that a partial validation is needed for method transfer between laboratories and in the current European Medicines Agency (EMEA) draft guidelines on method validation that the method transfer is necessary. No further elaboration was given, however, for how and when to conduct method transfer validation. Many strategic, procedural, and/or technical challenges/opportunities for a successful bioanalytical method transfer are still pending on further deliberation and clarification.