International Pharmaceutical Product Registration
eBook - ePub

International Pharmaceutical Product Registration

  1. English
  2. ePUB (mobile friendly)
  3. Available on iOS & Android
eBook - ePub

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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Information

Publisher
CRC Press
Year
2016
Topic
Technology & Engineering
eBook ISBN
9781040205921
Subtopic
Pharmacology
Index
Technology & Engineering

Table of contents

  1. Cover
  2. Half Title
  3. Title Page
  4. Drugs and the Pharmaceutical Sciences
  5. Copyright Page
  6. Preface
  7. Acknowledgements
  8. Table of Contents
  9. Contributors
  10. 1 The Common Technical Document—A Global Format for Registration Files
  11. 2 The Electronic Common Technical Document
  12. 3 CTD Module 1—Administrative Information
  13. 4 Environmental Risk Assessment
  14. 5 Quality Overall Summary
  15. 6 The Nonclinical Overview and Summary
  16. 7 The Clinical Overview and Summary
  17. 8 Drug Substance—General Information
  18. 9 Drug Substance-Manufacture
  19. 10 Drug Substance-Characterization
  20. 11 Control of Drug Substance
  21. 12 Drug Substance and Drug Product—Container/Closure
  22. 13 Drug Product-Description and Composition
  23. 14 Drug Product—Pharmaceutical Development
  24. 15 Drug Product—Manufacture and Process Validation
  25. 16 Drug Product—Excipients
  26. 17 Control Tests on the Finished Product
  27. 18 Reference Standards or Materials
  28. 19 Drug Substance and Drug Product Stability
  29. 20 Transmissible Spongiform Encephalopathy Agent and Adventitious Agent Requirements for Non-Biological Pharmaceutical Products
  30. 21 Nonclinical Testing Strategy
  31. 22 Pharmacology
  32. 23 Nonclinical Pharmacokinetics and Toxicokinetics
  33. 24 Single and Repeat Dose Toxicity
  34. 25 Genotoxicity
  35. 26 Carcinogenicity
  36. 27 Reproductive and Developmental Toxicity
  37. 28 Safety Pharmacology Testing: Past, Present, and Future
  38. 29 Immunotoxicology
  39. 30 Local Tolerance and Other Toxicity Studies
  40. 31 Bioavailability and Bioequivalence Studies
  41. 32 Pharmacokinetics in Man
  42. 33 Pharmacodynamics
  43. 34 Statistical Concepts in the Design and Analysis of Clinical Trials
  44. 35 Efficacy and Safety Clinical Studies
  45. 36 Postmarketing Evaluation
  46. 37 Pharmacovigilance and Risk Management
  47. 38 Pregnancy and Children
  48. 39 Ageing Populations and Development of Medicinal Products
  49. 40 Good Clinical Practice
  50. 41 Prevention and Detection of Fraud in Clinical Trials
  51. 42 Aspects of Biological and Biotechnological Medicinal Products
  52. 43 Device-Drug Combination Products
  53. 44 Recommendations for Toxicological Evaluation of Nanoparticle Medicinal Products9
  54. 45 Modeling and Medical Product R&D
  55. Annex 1: List of Acronyms and Abbreviations
  56. Annex 2: List of Key Technical and Regulatory Information Sources

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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 Technology & Engineering & Pharmacology. We have over 1.5 million books available in our catalogue for you to explore.