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•Article: Successful Stability Testing Strategies

Properly planned, executed and managed stability studies are critical for understanding data generated during clinical trials.

The approval of a drug for the marketplace relies heavily on the success or failure of the clinical trials. Equally important is the understanding of its stability both as an active pharmaceutical ingredient (API) and as a finished drug product (FDP).

As with clinical trials, it is imperative to properly plan, document and manage stability study cycles or programs. There are several items to be considered and planned for which, if addressed, can result in reliable information-rich data or, if overlooked, may result in investigations or jeopardize approval of the drug.

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•Article: Successful Stability Testing Strategies