美国FDA 指导原则 创新药物开发、制造和质量保证的PAT_A框架 英文原版.pdfVIP

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美国FDA 指导原则 创新药物开发、制造和质量保证的PAT_A框架 英文原版.pdf

Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) Pharmaceutical CGMPs September 2004 Guidance for Industry PAT — A F

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