随着新药研制的增多,新药申报资料水平有了很大的提高,并向规范化、标准化发展。但在新药审核工作中发现,申报资料仍有不少问题。如有的新药药理毒理试验由于没有按新药审批办法有关的技术要求进行,导致重做或补做动物试验。特别是长期毒性试验,试验周期长,重做或补做试验直接拖延了新药审核审批速度。现将药理毒理学研究资料存在的问题归纳如下,供参考。 1.药效学试验 With the increase of new drug research and development, the level of new drug application information has been greatly improved and has been standardized and standardized. However, in the new drug audit found that there are still many problems reporting information. If some of the new drug pharmacology and toxicology test as a result of new drug approval methods related to the technical requirements, resulting in redo or make animal tests. Especially long-term toxicity test, long test period, redo or make-up test directly delayed the approval of new drug approval speed. The pharmacological and toxicological research data now exist as follows, for reference. Pharmacodynamic test