作为一个新药的药理申报资料,应该考虑以下几点:1.能否说明该药的有效性,2.能否说明该药的安全性;3.药理及毒理试验的整体设计是否合理。现从药效及毒理两方面分别讨论如下。 As a pharmacological application for a new drug, the following points should be considered: 1. Can it demonstrate the effectiveness of the drug, 2. Can it describe the safety of the drug, 3. Does the overall design of pharmacological and toxicological tests are reasonable? The two aspects of pharmacodynamics and toxicology are discussed separately below.