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DRUG QUALITY SYSTEM FOR THE 21 ST CENTURY PQRI/FDA April 22-24

DRUG QUALITY SYSTEM FOR THE 21 ST CENTURY PQRI/FDA April 22-24. CHANGES WITHOUT PRIOR APPROVAL AN FDA PERSPECTIVE Dennis M. Bensley, Jr., Ph.D. Center for Veterinary Medicine, FDA. OUTLINE. INTRODUCTION BACKGROUND CURRENT FDA ASSESSMENT CURRENT RISK ANALYSIS COMPARABILITY PROTOCOL

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1.2k views • 63 slides

PTIT for DCU of OINDP: Approaches to Resolution of Identified Issues

PTIT for DCU of OINDP: Approaches to Resolution of Identified Issues. Wallace P. Adams, Ph.D. OPS/IO Advisory Committee for Pharmaceutical Science 21 October 2003 Rockville, MD. Outline. Current DCU and SCU Tests Parametric Tolerance Interval Test (PTIT) Consensus Points OPS Issues

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513 views • 25 slides

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DRUG QUALITY SYSTEM FOR THE 21 ST CENTURY PQRI/FDA April 22-24

PTIT for DCU of OINDP: Approaches to Resolution of Identified Issues