OVERVIEW OFITFG/IPAC-RS COLLABORATIONFOR PRESENTATION TO THEADVISORY COMMITTEE FORPHARMACEUTICAL SCIENCE Presented by: Harris Cummings, PhD15 November 2000Rockville, MD

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Table of Contents

OVERVIEW OFITFG/IPAC-RS COLLABORATIONFOR PRESENTATION TO THEADVISORY COMMITTEE FORPHARMACEUTICAL SCIENCE Presented by: Harris Cummings, PhD15 November 2000Rockville, MD

ITFG/IPAC-RS TECHNICAL TEAM BA/BE IN VITRO AND IN VIVO TESTSPresented by: Lars Borgström, PhD 15 November 2000Rockville, MD

ITFG/IPAC-RS BA/BE TECHNICAL TEAM RESPONSES TO AGENCY’S BA/BE QUESTIONS RAISED AT OINDP SUBCOMMITTEE MEETINGPresented by: Les Harrison, PhD 15 November 2000Rockville, MD

ITFG/IPAC-RS COLLABORATION FDA QUESTION EVALUATION

OVERVIEW OF COLLABORATION RESPONSES

ITFG/IPAC-RS TECHNICAL TEAM CMC SPECIFICATIONSPresented by: Bo Olsson, PhD15 November 2000Rockville, MD

ITFG/IPAC-RS TECHNICAL TEAMS CMC LEACHABLES AND EXTRACTABLES ANDCMC SUPPLIER QUALITY CONTROLPresented by: Gordon Hansen15 NovemberRockville, MD

ITFG/IPAC-RS COLLABORATION CONCLUDING REMARKSPresented by: Cynthia Flynn, PhD15 November 2000Rockville, MD

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