Overview

Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more. TOC:

Full Product Details

Author:   Chandrahas Sahajwalla ,  Chandrahas G Sahajwalla
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Volume:   v. 141
Dimensions:   Width: 15.20cm , Height: 3.30cm , Length: 22.90cm
Weight:   0.952kg
ISBN:  

9780824754655

ISBN 10:   0824754654
Pages:   602
Publication Date:   24 May 2004
Audience:   Professional and scholarly ,  Professional and scholarly ,  Professional & Vocational ,  Postgraduate, Research & Scholarly
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

Introduction to Drug Development and Regulatory Decision-Making Larry Lesko; Evolution of Drug Development and its Regulatory Process Hank Malinowski; Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application Mehul Mehta; New Drug Application Content and Review Process for Clinical Pharmacology and Biopharmaceutics Chandra Sahajwalla; In-Vitro Drug Metabolism Studies During Development of New Drugs Shiew-Mei Huang; Drug Transporters Xiaoxiong Wei; Principles, Issues, and Applications of Interspecies Scaling Iftekhar Mahmood; Analytical Method Validation Brian Booth; Studies of the Basic Pharmacokinetic Properties of a Drug: A Regulatory Perspective Maria Sunzel; Surrogate Markers in Drug Development Jurgen Venitz; Population Pharmacokinetic and Pharmacodynamic Analysis Jogarao V. S. Gobburu; Scientific and Regulatory Considerations for Studies in Special Population Chandra Sahajwalla; Conducting Clinical Pharmacology Studies in Pregnant and Lactating Women Kathleen Uhl

Reviews

...the chapters are readable, the figures are clear in reproduction, the result being a useful text that I believe meets its goal of being an introductory text to drug development from a pharmacokinetic regulatory point-of-view. -Pharmaceutical Research ...a timely book which combines the scientific and regulatory aspects of clinical pharmacology and biopharmaceutics in easy-to-understand chapters that cover all aspects of drug development....fills an existing void and further provides a quick reference guide for the industrial or academic scientist who is new in the field. - . Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, and Acting Deputy Commissioner for Operations, Food and Drug Administration

the chapters are readable, the figures are clear in reproduction, the result being a useful text that I believe meets its goal of being an introductory text to drug development from a pharmacokinetic regulatory point-of-view. -Pharmaceutical Research a timely book which combines the scientific and regulatory aspects of clinical pharmacology and biopharmaceutics in easy-to-understand chapters that cover all aspects of drug development.fills an existing void and further provides a quick reference guide for the industrial or academic scientist who is new in the field. - . Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, and Acting Deputy Commissioner for Operations, Food and Drug Administration

Author Information

Chandrahas Sahajwalla

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