Regulatory Stability in Drug Development

Stability studies on both the API and the formulated product are required at all stages of clinical development. The expectation from the regulatory agencies is that a shelf-life sufficient to cover the use of the material in the intended clinical trial will be assigned, and that it can be justified based on scientific data.

Stability testing is an important part of any product regulatory submission. Stability data will be required on both the drug substance (API) and the formulation(s). The Guidance documents from ICH (International Conference on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) have standardized the data requirements in the three ICH regions (Europe, Japan and the United States). However, there are some exceptions, particularly for products intended for use in very hot and humid climates.

Regulatory stability usually refers to the formal stability studies in the eventual commercial container that will be used to support the shelf-life claim in the marketing application (viz. NDA in the US). The stability studies are required to be carried out using materials manufactured using the intended commercial process and greater than 1/10th the intended commercial scale.

FinnBrit Consulting has the experience to be able to advise clients on how to organize their regulatory stability programs.

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