Overview of Drug Developmentthe Regulatory Process：药物发展的监管过程概述.pptVIP

下载本文档

9
0
约9.2千字
约 26页
2018-03-13 发布于湖北
举报
版权申诉

Overview of Drug Developmentthe Regulatory Process：药物发展的监管过程概述.ppt

1、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。。
2、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
3、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
4、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
5、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
6、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
7、VIP文档为合作方或网友上传，每下载1次，网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档

Overview of Drug Developmentthe Regulatory Process：药物发展的监管过程概述

Overview of Drug Development:the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger D. Nolan B.Sc. (Hons), Biochemistry, LaTrobe University, Australia Ph.D., Biochemistry and Pharmacology, University of Melbourne, Australia Visiting Fellowship, Eicosanoids, NIEHS, RTP Visiting Fellowship, Platelet Signal Transduction, Burroughs Wellcome, RTP Assistant Professor, Biochemistry and Internal Medicine, EVMS, Norfolk Director, Pharmacology, Insmed Pharmaceuticals, Richmond Senior Scientist, Drug Development, Cato Research, Durham Director, Project Operations, Calvert Research Institute, Cary * The New Drug Development Process (/cder/handbook/develop.htm) * Clinical Trials ? Preclinical Testing File IND at FDA Phase I Phase II Phase III File NDA at FDA FDA ? Phase IV Years 3.5 1 2 3 2.5 12 Total Additional Post marketing testing required by FDA Test Population Laboratory and animal studies 20 to 80 healthy volunteers 100 to 300 patient volunteers 1000 to 3000 patient volunteers Review process / Approval ? Purpose Assess safety and biological activity Determine safety and dosage Evaluate effectiveness, look for side effects Verify effectiveness, monitor adverse reactions from long-term use Success Rate 5,000 compounds evaluated 5 enter trials 1 approved Basic Disciplines of Drug Development * Acronyms FDA IND NDA sNDA ANDA BLA PLA ELA 510(k) IDE PMA CMC GMP GLP GCP QC QA AWC EMEA HPB MHW ICH * Organization of the FDA Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) * Basic Disciplines of Drug Development Chemistry, Manufacturing, and Controls Nonclinical Clinical * Basic Disciplines of Drug Development Chemistry, Manufacturing, and Controls Discovery (serendipity, folk medicine, random screening, rational drug design) Chemistry