Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients

• 主要な著者: Naseem A. Charoo (著者), Omotayo Akanji (著者), Ziyaur Rahman (著者), Aqeel A. Khan (著者), Aqal Badshah (著者)
• フォーマット: 図書
• 出版事項: MDPI AG, 2024-07-01T00:00:00Z.
• 主題: article
• オンライン･アクセス: Connect to this object online.

Drug substances and excipients must be stored in recommended storage conditions and should comply with their specifications during the retest period for their use in the manufacture of drug products. The ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for H...