Published Articles

The Central Role Of Analytic Method Development And Validation In Pharmaceutical Development

Analytic method development, validation, and transfer are key elements of any pharmaceutical development program. This article will focus on development and validation activities as 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 methodrelated 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.

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