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In this white paper, we detail IVRT methods pertaining to generic and innovator products and discuss their potential benefits in terms of quality, time, and cost. An associated case study illustrates key design and formulation considerations and ways to avoid common pitfalls.

In this white paper, we introduce the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, Sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.