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

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

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Overview of Drug Development:the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Background: The New Drug Development Process (/cder/handbook/develop.htm) 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 (synthesis, purification, scale-up) Analytical (chemical structure and activity, excipients, purity and stability) Pharmaceutical (dosage form, route of administration, packaging and labeling) Good Manufacturing Practice (GMP): Guidelines related to manufacturing practices and specifications Focus on impurities Necessary to ensure quality of drug product (finished dosage form) and drug substance (bulk ingredients) Basic Disciplines of Drug Development Nonclinical Testing in laboratory (in vitro) and in animal models (in vivo) to assess safety and efficacy Objectives: To develop the pharmacological profile To determine the acute toxicity in at least 2 animal species To assess toxicity with studies ranging from 2 weeks to several months Good Laboratory Practice (GLP): Guidelines related to studies in animal models To ensure the quality and integrity of data by establishing basic standards for the conduct and reporting of nonclinical safety studies Basic Disciplines of Drug Development Investigational New Drug (IND) Application Pre-IND Meeting Request Pre-IND Meeting package Pre-IND Meeting Pre-IND Meeting Package 25-75 pages Agenda/Attendees/Objective Questions CMC information Nonclinical information Phase 1 protocol