新药开发的一般程序.pdf

Chapter 3 New Drug Development Shanghai Jiao Tong University 1. 新药研究与开发的全过程 新药研究的两个阶段：研究与开发 活性资源(Compounds) 新药研究 1.先导化合物的(Lead Dicovery) (Research) 2.先导化合物的结构优化(Modification) 侯选药物 (Candidate) 药物开发 1.临床前研究(Preclinical) 2.临床研究(Clinical) Development 新药(New Drug) Shanghai Jiao Tong University 2. New drug application of FDA 1) New drug application,NDA 2) Abbreviated new drug application ANDA (专利过期药物申请) 3) Over the counter (OTC) Shanghai Jiao Tong University 3. New drug application course of FDA 临床前研究 临床研究 新药评审 （评审例会） Shanghai Jiao Tong University 4. Preclinical development and investigational new drug application(INDA) (1) Chemistry, manufacturing, and quality control studies: ① A description of the drug substance, including its physical, chemical, or biological characteristics ② The general method of preparation of the drug substance; ③ Identification of structure of drug substance; ④ The acceptable limits and analytical methods used to assure the identity, quality, and purity of the drug substance; ⑤ Information to support the stability of the drug substance; ⑥ Drug product information(formula, preparation and quality etc) Shanghai Jiao Tong University (2) Animal pharmacology and toxicology studies: ① Pharmacological effects and mechanism(s) of actions studies involve a variety of experimental methods depending on clinical orientation. ②General pharmacology studies(safety pharmacology studies ) General pharmacology studies were originally referred to as those designed to examine effects other than the primary therape