• Strategic Timing for Defining Regulatory Starting Materials (RSMs)

  • Oct 24 2024
  • Length: 4 mins
  • Podcast

Strategic Timing for Defining Regulatory Starting Materials (RSMs)

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  • Summary

  • 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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