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标题:Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description
时间:2020-10-29 10:00:38
DOI:10.1007/s12247-018-9340-2
大小:1583 kb
页数:15 PAGES
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目录:
  • Part...
    • Abstract
    • Introduction
      • Case Study 1: Multifactor Process Understanding to Control Impurities
        • Introduction
        • Risk Assessment Activities
      • Case Study 2: Manufacturing Process Description Flexibility
        • Introduction
      • Case Study 3: Flexible Scalability of a Hybrid Flow-Batch Process
      • Case Study 4: Design Space for Control of CQA Impurities in Drug Substance X
      • Case Study 5: Development of a Control Strategy for a Final Intermediate to Enable Impurities Control [18]
        • Summary
    • Conclusions
    • References
      • Case Study 1 & 2
      • Case Study 2
      • Case Study 3
      • Case Study 5

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