• Setting Drug Specifications in Data-Limited Scenarios

  • 2024/12/12
  • 再生時間： 21 分
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Setting Drug Specifications in Data-Limited Scenarios

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  • This Podcast offers a structured approach to setting drug specifications when data is limited. It emphasizes a risk-based strategy using industry standards and conservative initial ranges, iteratively tightened as more data becomes available. The process includes focused data collection, regulatory compliance, and Quality by Design principles. Cross-functional collaboration and thorough documentation are crucial for ensuring product quality, manufacturability, and regulatory success. Ultimately, the guide provides a roadmap for navigating the complexities of specification setting in data-scarce pharmaceutical development.

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あらすじ・解説

This Podcast offers a structured approach to setting drug specifications when data is limited. It emphasizes a risk-based strategy using industry standards and conservative initial ranges, iteratively tightened as more data becomes available. The process includes focused data collection, regulatory compliance, and Quality by Design principles. Cross-functional collaboration and thorough documentation are crucial for ensuring product quality, manufacturability, and regulatory success. Ultimately, the guide provides a roadmap for navigating the complexities of specification setting in data-scarce pharmaceutical development.

Support the show
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