Christ W
Institute for Drugs, Federal Health Office, Berlin, FRG.
Eur J Clin Microbiol Infect Dis. 1990 Jul;9(7):537-41. doi: 10.1007/BF01964299.
Evaluation of antimicrobial agents in governed mainly by interaction between the pharmaceutical industry and regulatory authorities. The 1977 FDA guidelines have been setting the standards for more than a decade now. Basic principles of the 1977 guidelines remain valid, however changes in the definition of end-points of response, as measured by both clinical and microbiological criteria, have occurred. The new (draft) FDA guidelines and the 1989 guidelines of the British Society of Antimicrobial Chemotherapy are more consistent with contemporary concepts of treatment. In general, the differences in the requirements are minimal with a few exceptions, namely the requirements concerning blinding and assessment of clinical efficacy by site of infection and by organism in the FDA guidelines.
抗菌药物的评估主要由制药行业与监管机构之间的互动来主导。1977年美国食品药品监督管理局（FDA）的指南至今已设定标准达十多年之久。1977年指南的基本原则仍然有效，不过，在以临床和微生物学标准衡量的反应终点定义方面已经发生了变化。FDA的新（草案）指南和英国抗菌化疗学会1989年的指南与当代治疗理念更为一致。总体而言，要求上的差异微乎其微，仅有少数例外情况，即FDA指南中关于盲法以及按感染部位和病原体评估临床疗效的要求。
