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自1979年6月20日美国颁布和实施GLP(非临床安全性实验管理规范)以来,广大受监督单位提出了大量问题,为保证解释一致性和精确性,FDA有关官员分别作了解答。 FDA对各种解答做了广泛收集和整理,经FDA有关部门审核,现已成文。现将此内容编译,供读者参考。 (Ⅰ)通则一、范围1.GLP是否适用于认证试验,以便证实测定受试品在动物组织和药物制剂中的浓度而
Since the promulgation and implementation of the GLP (Non-Clinical Laboratory Safety Management Practices) by the United States on June 20, 1979, a large number of supervised units have raised a great deal of questions. Relevant officials from the FDA have respectively answered questions about consistency and accuracy of interpretation. The FDA has extensively collected and collated all kinds of answers and has been written and reviewed by the relevant departments of the FDA. Now compile this content for readers reference. (I) General Provisions I. Scope 1. Whether GLP is suitable for certification testing in order to confirm the determination of the concentration of test articles in animal tissues and pharmaceutical preparations