Strategic Timing for Defining Regulatory Starting Materials (RSMs)
Manage episode 446638805 series 3603634
The episode "Strategic Timing for Defining Regulatory Starting Materials (RSMs)" highlights the impact of timing when defining RSMs during Active Pharmaceutical Ingredient (API) development. It examines three stages—Pre-IND, Post-IND but pre-clinical trials, and late development before submission—each with its own advantages and challenges. Early-stage definitions offer flexibility but limited regulatory guidance, mid-stage definitions align with initial regulatory interactions but reduce flexibility, while late-stage definitions are data-backed but difficult to adjust. The episode emphasizes balancing flexibility and regulatory alignment, advocating for a collaborative, data-driven approach to ensure efficient development and compliance.
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