美国FDA 指导原则 IND人类药物和生物制品化学制造和控制信息会议 英文原版.pdfVIP

Guidance for Industry IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information 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) May 2001 CMC Guidance for Industry IND Meetings for Human Drugs and Biologics Chemistry