Arcieri G
Ann Intern Med. 1978 Nov;89(5 Pt 2 Suppl):838-41. doi: 10.7326/0003-4819-89-5-838.
The network for development of a new antimicrobial drug, from discovery of the compound to submission of the New Drug Application, is reviewed. The key problems encountered during this process, as elucidated through a survey of 62 American pharmaceutical companies, include difficulties in discovering new and significant antimicrobial drugs, the unpredictability of in-vitro and animal studies, lack of specific criteria for the bacteriologic response to therapy, difficulties in setting up well-controlled clinical studies, and difficulty with the timely enrollment of suitable patients with precise microbiologic diagnosis before treatment.
本文综述了一种新型抗菌药物从化合物发现到新药申请提交的研发网络。通过对62家美国制药公司的调查揭示，这一过程中遇到的关键问题包括：发现新的和有显著疗效的抗菌药物存在困难；体外和动物研究具有不可预测性；缺乏治疗细菌学反应的具体标准；开展严格对照的临床研究存在困难；以及在治疗前及时招募具有精确微生物诊断的合适患者存在困难。
