ICH 有机溶剂CLASS 分类标准.pdf

Guidance for Industry Q3C — Tables and List 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) November 2003 ICH Revision 1 Guidance for Industry Q3C — Tables and List Additional copies are available from: Center for Drug Evaluation and Research (CDER) Division of Drug Information (HFD-240) Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm or Office of Communication, Training, and Manufacturers Assistance (HFM-40) Center for Biologics Evaluation and Research (CBER) Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448 /cber/guidelines.htm; (Tel) Voice Information System at 800-835-4709 or 301-827-1800 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) November 2003