新药报批资料不同于科学论文,其中毒性实验的目的,不仅在于说明某新药的安全性,更应着重阐明一旦药物过量,将对机体产生何种影响,毒性靶器官何在,为临床安全用药提供信息。各项报批资料间的剂量呼应问题尤应注意。为了提高新药报批资料的质量及提高通过审评率,现就其中若干易被忽视的问题进行讨论。 The new drug approval information is different from scientific papers. The purpose of the toxicity experiment is not only to illustrate the safety of a new drug, but also to clarify what effect the drug will have on the body once the drug is overdosed. Where are the toxic target organs? Provide information for clinical safety medication . Dose between the various approved information should pay attention to the issue of dose. In order to improve the quality of the information approved by the new drugs and to raise the rate of passing the review, some issues that are neglected are discussed.