OVERVIEW OF ITFG/IPAC-RS COLLABORATION FOR PRESENTATION TO THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE Presented by: Harris Cummings, PhD 15 November 2000 Rockville, MD

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OVERVIEW OF ITFG/IPAC-RS COLLABORATION FOR PRESENTATION TO THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE Presented by: Harris Cummings, PhD 15 November 2000 Rockville, MD

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

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

ITFG/IPAC-RS COLLABORATION FDA QUESTION EVALUATION

OVERVIEW OF COLLABORATION RESPONSES

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ITFG/IPAC-RS TECHNICAL TEAM CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 15 November 2000 Rockville, MD

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ITFG/IPAC-RS TECHNICAL TEAMS CMC LEACHABLES AND EXTRACTABLES AND CMC SUPPLIER QUALITY CONTROL Presented by: Gordon Hansen 15 November Rockville, MD

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ITFG/IPAC-RS COLLABORATION CONCLUDING REMARKS Presented by: Cynthia Flynn, PhD 15 November 2000 Rockville, MD

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Author: GCD User