新药的审评是一项技术性政策性强,又严肃细致的工作。现结合几年来我省受理新药初审的情况,提出以下若干应注意的问题。一、剂型选择理想的药物剂型应是:有效性、安全性、稳定性、生物等效性、均匀性和适用性的统一。例如肠道驱虫片改为混悬剂仍口服,由于工艺上采用胶体磨,要了解过细的微粒是否会因增加吸收而增加 The review of new drugs is a technical policy and a serious and meticulous work. Now with the situation of our province accepting the preliminary examination of new drugs over the past few years, we have put forward the following issues that should be noted. First, the dosage form The ideal pharmaceutical dosage form should be: the unity of effectiveness, safety, stability, bioequivalence, homogeneity and applicability. For example, the intestinal repellent tablets were changed to suspensions and they were still taken orally. Since colloid mills are used in the process, it is necessary to understand whether the fine particles will increase due to increased absorption.