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Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition / Edition 2
     

Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition / Edition 2

by Martin D. Hynes, Hynes III Hynes III, Hynes III Martin D
 

ISBN-10: 0849391849

ISBN-13: 9780849391842

Pub. Date: 03/03/2008

Publisher: Taylor & Francis

Clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market.

Overview

Clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market.

Product Details

ISBN-13:
9780849391842
Publisher:
Taylor & Francis
Publication date:
03/03/2008
Series:
Drugs and the Pharmaceutical Sciences Series , #181
Edition description:
REV
Pages:
304
Product dimensions:
6.20(w) x 9.10(h) x 0.80(d)

Table of Contents

Introduction/Preface. Pre-Approval Inspection: A Historical Overview. Recent Trends in Domestic and International Pre-Approval Inspections. The Implications of the Quality Systems, Risk Based Inspections and 21st Century GMPs to Preparing for FDA Pre-Approval Inspections. Preparing for FDA Pre-Approval Inspections Similarities and Differences between Center for Biologics Evaluation and Research (CBER) / Center for Drug Evaluation and Research (CDER). The GMP Risk Assessment, Guidance for Preparing for Pre-Approval Inspections, Traditional and Non-Traditional. The Product Development Drill, the Importance of Good Science, Stability Data, Scale Up, and Validation to Successfully Passing a Pre-Approval Inspection. The History of Development Documents: Guidance for Preparation in Light of Recent Trends. Computer Validation Systems Validation during the Drug Development Process. The Use of Audits during the Drug Development Process to Assure a Successful Pre-Approval Inspection. The Consequence of a Poor Product Development Process and Failing a Pre-Approval Inspection.

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