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· 제목 : Handbook of Biogeneric Therapeutic Proteins : Regulatory, Manufacturing, Testing, and Patent Issues (Hardcover, 2 ed)
· 분류 : 외국도서 > 의학 > 임상의학
· ISBN : 9781032489605
· 쪽수 : 412쪽
· 출판일 : 2024-04-15
· 분류 : 외국도서 > 의학 > 임상의학
· ISBN : 9781032489605
· 쪽수 : 412쪽
· 출판일 : 2024-04-15
목차
Chapter 1 Biosimilar Biopharmaceuticals
Chapter 2 Regulatory Requirements
Chapter 3 Development Master Plan
Chapter 4 Trends in Recombinant Proteins Manufacturing
Chapter 5 Analytical Assessment
Chapter 6 Clinical Pharmacology Assessment
Chapter 7 Clinical Immunogenicity Assessment
Chapter 8 Clinical Efficacy Assessment
Chapter 9 Recombinant Manufacturing System
Chapter 10 Upstream Processing
Chapter 11 Downstream Process
Chapter 12 Formulation of Biopharmaceuticals
Chapter 13 Quality and Compliance Systems
Chapter 14 Intellectual Property Issues for Scientists
Chapter 15 Advances in Biomanufacturing
