Bass R, Lehnert T
Institute for Drugs, Federal Health Office, Berlin, FRG.
Eur J Clin Microbiol Infect Dis. 1990 Jul;9(7):488-91. doi: 10.1007/BF01964288.
The regulations in different countries on the toxicological testing of antimicrobial agents are similar and harmonized on an international basis. Existing requirements cover both the standard investigations performed with any other new class of therapeutic drug and investigations necessary due to the specific features of anti-infective agents. Such features are the therapeutic target (the microorganisms), the need to provide adequate treatment of patients even during clinical trials, and the potential of the drug to induce certain adverse reactions. The combination of toxicity tests used will be determined by the drug, its class and current knowledge.
不同国家对抗菌药物毒理学测试的规定相似且在国际层面上相互协调。现有要求既涵盖了对任何其他新型治疗药物所进行的标准调查，也包括因抗感染药物的特殊特性而必需的调查。这些特性包括治疗靶点（微生物）、即使在临床试验期间也需要为患者提供充分治疗，以及药物诱发某些不良反应的可能性。所采用的毒性测试组合将由药物、其类别和现有知识来决定。
