New Drug Development
eBook - PDF

New Drug Development

Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

  1. 500 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

New Drug Development

Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

About this book

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

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Yes, you can access New Drug Development by Chandrahas Sahajwalla in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2004
Print ISBN
9780824754655
eBook ISBN
9780203026427
Edition
1
Topic
Medicine
Subtopic
Pharmacology

Table of contents

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