Stability Blog Series | Stability Testing Regulatory Expectations Approaching an IND Submission

Stability studies play a fundamental role across the lifecycle of pharmaceutical products and, in particular, across all phases of the IND, to demonstrate that a new drug substance (DS) and drug product (DP) are within acceptable chemical and physical limits for the planned duration of the proposed clinical investigation.

In this edition of our stability blog series, our expert Teresa Iley, Director of Pharmaceutical Development and Manufacture, discusses the regulatory expectations, the types of studies and key considerations when approaching an IND Submission.

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