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

By Robert W. Lee, PhD and Laurie Goldman

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 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. 

Effective method development ensures that laboratory resources are optimized, while methods meet the objectives required at each stage of drug development. Method validation, required by regulatory agencies at certain stages of the drug approval process, is defined as the “process of demonstrating that analytical procedures are suitable for their intended use.” Method transfer is the formal process of assessing the suitability of methods in another laboratory. Each of these processes contributes to continual improvement of the methods and results in more efficient drug development. Analytic methods are intended to establish the identity, purity, physical characteristics and potency of the drugs that we use. Methods are developed to support drug testing against specifications during manufacturing and quality release operations, as well as during long-term stability studies. Methods may also support safety and characterization studies or evaluations of drug performance.