2、药理、毒理研究.pptVIP

* 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,