美国FDA 指导原则 待处理ANDAS中活性药物成分的替代来源 英文原版.pdfVIP

Guidance for Industry Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) December 2000 Office of Generic Drugs Guidance for Industry Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs