de Cea Lavech de Chancy H
División de Especialidades Farmacéuticas, Laboratorios Pierre Fabre, Barcelona.
Rev Clin Esp. 1990 Sep;187(4):184-90.
Pharmacological investigation provides drugs which are progressively more active, the therapeutic effect of which is inseparably bound to the possibility of provoking adverse effects. At the present time, drug safety can be evaluated at three levels: animal experiments, clinical studies and post marketing surveillance. A new drug is admitted in view of the results obtained through-out its development both in preclinical and clinical studies, when the benefits obtained are superior to the risks, in case of a particular disease, and based on the information available at that moment. Postmarketing surveillance permits the identification and quantification of adverse effects caused by commercialized drugs. Keeping in mind that drug safety is never absolute, everybody including physicians, government administration, and pharmaceutical industries, should be motivated in order to obtain efficacious and safe drugs in a climate of strictness, dialogue and realism.
药理学研究提供了活性越来越高的药物，其治疗效果与引发不良反应的可能性紧密相连。目前，药物安全性可在三个层面进行评估：动物实验、临床研究和上市后监测。鉴于一种新药在临床前和临床研究整个研发过程中所取得的结果，当在特定疾病情况下所获得的益处超过风险时，并基于当时可获得的信息，该新药便可获批上市。上市后监测能够识别并量化已上市药物所引发的不良反应。要牢记药物安全性绝非绝对的，包括医生、政府管理部门和制药行业在内的每一个人，都应受到激励，以便在严谨、对话和务实的氛围中获取有效且安全的药物。
