International Pharmaceutical Product Registration
eBook - PDF

International Pharmaceutical Product Registration

  1. 852 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

International Pharmaceutical Product Registration

About this book

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou

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Yes, you can access International Pharmaceutical Product Registration by Anthony C. Cartwright,Brian R. Matthews in PDF and/or ePUB format, as well as other popular books in Medicina & FarmacologĂ­a. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2016
Print ISBN
9781420081763
eBook ISBN
9781420081831
Edition
2
Topic
Medicina
Subtopic
FarmacologĂ­a

Table of contents

  1. Front Cover
  2. Preface
  3. Acknowledgements
  4. Contents
  5. Contributors
  6. Chapter 1. The Common Technical Document—A Global Format for Registration Files
  7. Chapter 2. The Electronic Common Technical Document
  8. Chapter 3. CTD Module 1—Administrative Information
  9. Chapter 4. Environmental Risk Assessment
  10. Chapter 5. Quality Overall Summary
  11. Chapter 6. The Nonclinical Overview and Summary
  12. Chapter 7. The Clinical Overview and Summary
  13. Chapter 8. Drug Substance—General Information
  14. Chapter 9. Drug Substance—Manufacture
  15. Chapter 10. Drug Substance—Characterization
  16. Chapter 11. Control of Drug Substance
  17. Chapter 12. Drug Substance and Drug Product—Container/Closure
  18. Chapter 13. Drug Product—Description and Composition
  19. Chapter 14. Drug Product—Pharmaceutical Development
  20. Chapter 15. Drug Product—Manufacture and Process Validation
  21. Chapter 16. Drug Product—Excipients
  22. Chapter 17. Control Tests on the Finished Product
  23. Chapter 18. Reference Standards or Materials
  24. Chapter 19. Drug Substance and Drug Product Stability
  25. Chapter 20. Transmissible Spongiform Encephalopathy Agent and Adventitious Agent Requirements for Non-Biological Pharmaceutical Products
  26. Chapter 21. Nonclinical Testing Strategy
  27. Chapter 22. Pharmacology
  28. Chapter 23. Nonclinical Pharmacokinetics and Toxicokinetics
  29. Chapter 24. Single and Repeat Dose Toxicity
  30. Chapter 25. Genotoxicity
  31. Chapter 26. Carcinogenicity
  32. Chapter 27. Reproductive and Developmental Toxicity
  33. Chapter 28. Safety Pharmacology Testing: Past, Present, and Future
  34. Chapter 29. Immunotoxicology
  35. Chapter 31. Bioavailability and Bioequivalence Studies
  36. Chpater 32. Pharmacokinetics in Man
  37. Chapter 33. Pharmacodynamics
  38. Chapter 34. Statistical Concepts in the Design and Analysis of Clinical Trials
  39. Chapter 35. Efficacy and Safety Clinical Studies
  40. Chapter 36. Postmarketing Evaluation
  41. Chapter 37. Pharmacovigilance and Risk Management
  42. Chapter 38. Pregnancy and Children
  43. Chapter 39. Ageing Populations and Development of Medicinal Products
  44. Chapter 40. Good Clinical Practice
  45. Chapter 41. Prevention and Detection of Fraud in Clinical Trials
  46. Chapter 42. Aspects of Biological and Biotechnological Medicinal Products
  47. Chapter 43. Device-Drug Combination Products
  48. Chapter 44. Recommendations for Toxicological Evaluation of Nanoparticle Medicinal Products
  49. Chapter 45. Modeling and Medical Product R&D
  50. Annex 1: List of Acronyms and Abbreviations
  51. Annex 2: List of Key Technical and Regulatory Information Sources
  52. Back Cover