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· 분류 : 외국도서 > 교육/자료 > 참고자료 > 일반
· ISBN : 9781032919737
· 쪽수 : 452쪽
· 출판일 : 2024-10-14
목차
Part I Regulatory and Manufacturing
Chapter 1. Sterile Manufacturing Formulations Template
Chapter 2. Inspection of Sterile Product Manufacturing Facilities
Chapter 3. New Drug Application for Sterilized Products
Chapter 4. Validation of Cleaning Process
Chapter 5. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Chapter 6. Analysis of the Expression Construct in Cells Used for Production of rDNA-Derived Protein Products
Chapter 7. Stability Testing of Biotechnological/Biological Products
Chapter 8. Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
Chapter 9. Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
Chapter 10. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Chapter 11. Essential Clean-Room Design Elements
PartII Manufacturing Formulations
Sterile Product Formulations
Part III Commercial Pharmaceutical Formulations
Commercial Pharmaceutical Formulations
Index
