美国FDA 指导原则 单抗在药品生产中的应用 英文原版.pdfVIP

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美国FDA 指导原则 单抗在药品生产中的应用 英文原版.pdf

Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2001 Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing Additional copies are available from:

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