Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
复制标题
为人类药物和生物制品提供有效性临床证据的行业指南
DOI：
--
复制
发表时间：
1998
期刊：
影响因子：
--
通讯作者：
R. Pestell
中科院分区：
文献类型：
--
作者：
Mathew C. Casimiro;A. Arnold;R. Pestell
其他副本可从以下地址获取： 药物信息处 (HFD-210)、药物评估和研究中心 (CDER), 5600 Fishers Lane, Rockville, MD 20857（电话）301-827-4573 互联网：http://www.fda.gov/cder/guidance/index.htm 或交流、培训和制造商援助办公室 (HFM-40) 生物制品评估和研究中心(CBER) 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm （传真）888-CBERFAX 或 301-827-3844 （语音信息）800-835-4709 或 301-827-1800
Additional copies are available from: the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573 Internet at http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training, and Manufacturers Assistance (HFM-40) Center for Biologics Evaluation and Research (CBER) 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm (Fax) 888-CBERFAX or 301-827-3844 (Voice Information) 800-835-4709 or 301-827-1800