Juillet Y, Abadie E
Rev Med Interne. 1986 Nov;Spec No:21-7.
Determining the optimal dosage is an important step in the development of any drug, as it will provide a basis to demonstrate the effectiveness of that drug at different dosage levels. This determination is mainly attempted in phase II, notably by means of dose-response studies, but it is obvious that data obtained at every stage in the life of the drug will provide a better approach to dosage recommendations. Several examples are discussed.
确定最佳剂量是任何药物研发中的重要一步,因为它将为证明该药物在不同剂量水平下的有效性提供依据。这一确定主要在II期进行尝试,尤其是通过剂量反应研究,但显然在药物研发的每个阶段获得的数据将为剂量推荐提供更好的方法。文中讨论了几个例子。