• The Role of API Process Development in CMC Drug Development

  • 2024/12/03
  • 再生時間： 16 分
  • ポッドキャスト

The Role of API Process Development in CMC Drug Development

無料で聴く

ポッドキャストの詳細を見る

  • サマリー

  • This Podcast discusses the critical role of API process development in the Chemistry, Manufacturing, and Controls (CMC) drug development process. This process focuses on ensuring the drug substance or API (Active Pharmaceutical Ingredient) can be manufactured consistently and safely at scale. The text explains the different stages of API process development, from the early preclinical phase where synthetic routes are developed, to later stages where these routes are optimized for scalability and cost-effectiveness. The text then explores challenges in API process development, such as the complexity of chemical reactions involved in drug synthesis and the need to balance cost and quality. Finally, the text distinguishes between small molecule APIs and biologics, highlighting the unique complexities associated with each.

    Support the show
    続きを読む 一部表示

あらすじ・解説

This Podcast discusses the critical role of API process development in the Chemistry, Manufacturing, and Controls (CMC) drug development process. This process focuses on ensuring the drug substance or API (Active Pharmaceutical Ingredient) can be manufactured consistently and safely at scale. The text explains the different stages of API process development, from the early preclinical phase where synthetic routes are developed, to later stages where these routes are optimized for scalability and cost-effectiveness. The text then explores challenges in API process development, such as the complexity of chemical reactions involved in drug synthesis and the need to balance cost and quality. Finally, the text distinguishes between small molecule APIs and biologics, highlighting the unique complexities associated with each.

Support the show
続きを読む 一部表示

The Role of API Process Development in CMC Drug Developmentに寄せられたリスナーの声

カスタマーレビュー：以下のタブを選択することで、他のサイトのレビューをご覧になれます。

Audible.co.jp

Amazon.co.jp
レビューはまだありません。