New Drug Development

Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

Chandrahas Sahajwalla

• Publisher: CRC Press
• Year: 2004
• Print ISBN:
  9780824754655
• eBook ISBN:
  9781135533489
• Topic: Medicine
• Subtopic: Pharmacology

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

Table of contents

• Cover Page
• Title Page
• Drugs and The Pharmaceutical Sciences
• Drugs and The Pharmaceutical Sciences
• Title Page
• Foreword
• Preface
• Acknowledgements
• Table of Contents
• Contributors
• 1 Introduction to Drug Development and Regulatory Decision-Making
• 2 Evolution of Drug Development and its Regulatory Process
• 3 Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application
• 4 New Drug Application Content and Review Process for Clinical Pharmacology and Biopharmaceutics
• 5 In-vitro Drug Metabolism Studies During Development of New Drugs
• 6 Drug Transporters
• 7 Principles, Issues, and Applications of Interspecies Scaling
• 8 Analytical Method Validation
• 9 Studies of the Basic Pharmacokinetic Properties of a Drug—a Regulatory Perspective
• 10 Surrogate Markers in Drug Development
• 11 Population Pharmacokinetic and Pharmacodynamic Analysis
• 12 Scientific and Regulatory Considerations for Studies in Special Populations
• 13 Conducting Clinical Pharmacology Studies in Pregnant and Lactating Women
• 14 Scientific, Mechanistic and Regulatory Issues with Pharmacokinetic Drug-Drug Interactions
• 15 Assessing the Effect of Disease State on the Pharmacokinetics of the Drug
• 16 Clinical Pharmacology Issues Related to Specific Drug Classes During Drug Development
• 17 Issues in Bioequivalence and Development of Generic Drug Products
• 18 Regulatory Considerations for Oral Extended Release Dosage Forms and in vitro (Dissolution)/in vivo (Bioavailability) Correlations
• 19 In vivo Bioavailability/Bioequivalence Waivers
• 20 Bioavailability and Bioequivalence Issues for Drugs Administered via Different Routes of Administration; Inhalation/Nasal Products;
• 21 Scientific and Regulatory Issues in Development of Chiral Drugs
• 22 A Regulatory View of Liposomal Drug Product Characterization
• 23 Challenges in Drug Development: Biological Agents of Intentional Use
• 24 The Regulation of Antidotes for Nerve Agent Poisoning
• 25 Bioequivalence Assessment: Approaches, Designs, and Statistical Considerations