“Developing and Validating Dissolution Procedures for Improved Product Quality”
Drug manufacturers use in vitro dissolution performance tests for solid oral dosage forms, such as tablets and capsules, to assess the lot-to-lot quality of a drug product, guide development of new formulations, and ensure product quality and performance after changes in the manufacturing process. Like any performance test conducted in a regulated environment, the dissolution procedure must be properly developed and validated to achieve the best results.
A white paper from Synomics Pharma, titled “Developing and Validating Dissolution Procedures for Improved Product Quality”, discusses the general concepts and highlights some specific method validation guidelines used in developing and validating dissolution test procedures.
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