d'Azemar P, Alexandre C, Thomas J
Anesth Analg (Paris). 1980;37(9-10):537-42.
The development of new drugs by pharmaceutical firms proceeds through different phases, i. e. pre-clinical studies and stage I, II and III clinical studies, which normally result in authorization to market. Once the drug is on the market, however, further research work is required to perfect its use and complete our knowledge of it. Stage IV clinical trials, which may be termed "pharmacosurveillance", fall as much as the previous ones within the responsibilities of the pharmaceutical industry, since reports on side-effects are collected and these may have practical applications. Thus, clinical research may be shifted towards possible new indications, or new pharmacological studies may be undertaken to elucidate the mechanism of some side-effects, develop them if they are beneficial, or find a way of preventing them if they are indesirable. With these considerations in mind, the authors have developed a protocol of pharmacosurveillance aimed at determining, through a preliminary in vitro study, the origin of some adverse reactions of anaesthetic drugs. Depending on the results of these studies, clinical applications are considered.
制药公司研发新药要经历不同阶段，即临床前研究以及I、II、III期临床试验，这些通常会带来上市许可。然而，一旦药物上市，就需要进一步开展研究工作以完善其应用并加深我们对它的了解。IV期临床试验，可称为“药物监测”，与之前各阶段一样，很大程度上属于制药行业的职责范围，因为要收集副作用报告，而这些报告可能有实际应用价值。因此，临床研究可能会转向潜在的新适应症，或者开展新的药理学研究以阐明某些副作用的机制，若副作用有益则加以开发利用，若副作用有害则设法预防。基于这些考虑，作者制定了一项药物监测方案，旨在通过初步的体外研究确定某些麻醉药物不良反应的根源。根据这些研究结果来考虑临床应用。
