Analytic method development, validation, and transfer are key elements of any pharmaceutical development program applied to drug products. Often considered routine, too little attention is paid to them with regards for their potential to contribute to overall developmental time and cost efficiency.


These method-related activities are interrelated. They are iterative, particularly during early drug development phases. Parts of each process may occur concurrently or be refined at various phases of drug development. Changes encountered during drug development may require modifications to existing analytic methods. These modifications to the methods, in turn, may require additional validation or transfer activities, as shown below …