新药研发过程.ppt

new drug exploiture 2012.12.12 主讲：魏堆堆 6Steps 1、 new chemical entities(NCE) 2、 Investigational New Drug Application （IND) 3、Preclinicalstudies 4、Clinical trials 5、New drug approval （NDA） 6、Listed and monitoring Drug research and development is a systematic project involving multiple disciplines Molecular Biology Molecular Pharmacology Bioinformatics Medicinal Chemistry Computer Science Drug Analytical Chemistry Pharmacology Toxicology Pharmaceutics Pharmaceutical technology The discovery of new chemical entities Extract Plant：Periwinkle（长春花）——Vinblastine（长春碱）、Vincristine（长春新碱） Pacific yew tree（太平洋红豆杉树）——Taxol（紫杉醇） Animal：Insulin、Hormone、Smallpox vaccine Organic Synthesis Molecular Modification Preclinicalstudies Chemical synthesis Provide a sufficient amount of the compound (drug) as a pre-clinical trials, clinical research, small-scale and large-scale preparation of formulations, each step must be quality control and validation. Biological characteristics Pharmacology Drug Metabolism Toxicology Preformulation studies Physical and chemical properties The initial design of the prescription Clinical trials Clinical trials stage An average of 20 drug candidates eventually approved for marketing（Reference：FDA consumer，1987；21：12） New drug approval （NDA） After completion of the pre-clinical and clinical studies, can submit a new drug application (NDA) in order to be allowed to the listing of new products. Accepted FDA Audit Factory inspection FDA decided Listed and monitoring IV clinical studies and post-marketing surveillance Understanding the mechanism of action of the drug and scope; Study drug possible new therapeutic effect Need to supplement dose specifications After the listing of the side effects of drugs（Adverse drug reaction, ADR) Report Discovery and Reports FDA in 15 working days Annual report * * ?Today, Genomics and proteomics are turning to be the effective methods for the discovery of target, the identification of l