Keysser C H
Ann Clin Lab Sci. 1976 Mar-Apr;6(2):197-205.
Preclinical safety testing is one important step in the development of new medicines. The requirements of such testing are the subject of government regulations and may vary in details, but not in general principles, in different countries around the world. The approach to preclinical safety testing of new drugs is multidisciplinary and requires the expertise of members from many different fields of science. The procedures described are guidelines rather than fixed protocols; they are subject to modifications according to the specific phamracological nature of the drug to be tested and also to the preference of the individual investigator. Under certain circumstances, special studies are necessary, such as electron microscopy, histochemistry, radioautography, and cytogenetics,--just to name a few. Routine studies for the safety assessment of new drugs include: (1) acute studies, (2) multiple-dose studies including carcinogenicity tests, (3) studies of fertility and general reproductive performance, (4) teratology studies, (5) perinatal and postnatal studies, (6) multiple-generation studies and (7) irritation studies.
临床前安全性测试是新药研发中的重要一步。此类测试的要求是政府法规的主题，在世界不同国家可能细节有所不同，但总体原则相同。新药临床前安全性测试方法是多学科的，需要许多不同科学领域成员的专业知识。所描述的程序是指导方针而非固定方案；它们会根据待测试药物的具体药理学性质以及个别研究者的偏好进行修改。在某些情况下，需要进行特殊研究，如电子显微镜检查、组织化学、放射自显影和细胞遗传学等——仅举几例。新药安全性评估的常规研究包括：（1）急性研究，（2）包括致癌性测试的多剂量研究，（3）生育力和一般生殖性能研究，（4）致畸学研究，（5）围产期和产后研究，（6）多代研究以及（7）刺激性研究。
