Literature

Properly planned, executed and managed stability studies are critical to understanding the data generated during clinical trials. The approval of a drug for the marketplace hinges on the success or failure of the required human clinical trials. Also critical to a drug's approval is a clear 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 programs and cycles. There are many items to be considered in that planning which, if addressed correctly, can result in reliable information-rich data or, if overlooked, may result in an investigation and/or jeopardize drug approval.