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· 제목 : Technology Transfer: Drug Product Manufacturing Process (Paperback, 2023) 
· 분류 : 외국도서 > 의학 > 약학
· ISBN : 9783031322198
· 쪽수 : 110쪽
· 출판일 : 2024-06-18
· 분류 : 외국도서 > 의학 > 약학
· ISBN : 9783031322198
· 쪽수 : 110쪽
· 출판일 : 2024-06-18
목차
Chapter 1: Current Status of Technology Transfer
Chapter 2: Quality by Design (QbD) Process Design
Chapter 3: Quality Risk Management (QRM)
Chapter 4: Technology Transfer ProcessChapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies
Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management
Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products
Appendix 1- Technology Transfer Documents (TTD) Checklist
Appendix II- Technology Transfer Protocol (TTP)
Appendix III- Checklist for First Exhibit Batch Start-Up
Appendix IV- Case Study of Roller Compaction Process From Development To Scale-Up추천도서
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