ⅲ期临床试验.ppt

* 新药开发的管理 2007年4月16日，国家食品药品监督管理局发布了《药物非临床研究质量管理规范认证管理办法》。 * 新药开发的管理 2003年8月6日，国家食品药品监督管理局发布了《药物临床试验质量管理规范》。 * 25) Idea-to-new medicine road - Full Development phase In this Full Development stage, known as Phase lll, several thousand patients with the particular disease receive the drug in carefully controlled studies to test its safety, tolerability, and efficacy. Finally, if the compound has proved its worth in all these tests, it enters the Registration phase in which the data of its entire history are compiled and analyzed in a regulatory submission. This New Drug Application, or NDA, is submitted to the FDA for review. In parallel, a Marketing Authorization Application (MAA) is filed in Europe, followed by a Japanese NDA. Only after a successful regulatory review does the candidate become a new medicine. * 25) Idea-to-new medicine road - Full Development phase In this Full Development stage, known as Phase lll, several thousand patients with the particular disease receive the drug in carefully controlled studies to test its safety, tolerability, and efficacy. Finally, if the compound has proved its worth in all these tests, it enters the Registration phase in which the data of its entire history are compiled and analyzed in a regulatory submission. This New Drug Application, or NDA, is submitted to the FDA for review. In parallel, a Marketing Authorization Application (MAA) is filed in Europe, followed by a Japanese NDA. Only after a successful regulatory review does the candidate become a new medicine. * * 1、药学研究 2、药理、毒理研究 （一）新药临床前研究 * 1）新药的化学研究①性状②分子式、结构式的确定 ③理化常数④工艺流程 2）新药的质量标准 3）新药的剂型研究 1、药学研究 * （1）新药的药理学研究 ①药效学研究 ②药代动力学研究 2、药理、毒理研究 * （2）新药的毒理学研究 ①全身毒性 ②局部毒性 ③特殊毒性研究 ④药物依赖性试验 2、药理、毒理研究 * A. 与已知人体对其有依赖性作用的药物合化学结构有关的新药； B. 作用于中枢神经系统的新药如镇痛药，抑制 药，兴奋药 * （二）临床前研究的要求 1、GLP 2、药品 * * 临床试验的分期 Ⅰ 期临床试验 Ⅱ 期临床试验 Ⅲ 期临床试验 Ⅳ 期临床试验 * Ⅰ期临床试验 初步的临床药理学及人体安全性评价试验。 目的： 观察人体对于新药的耐受程度和药代动力学，为制定给药方案提供依据，处方、剂型的筛选。 试验组人数20-30例。 * 内容： 初始人体安全性和耐受性评估 药物代谢动力学