Handbook of Bioequivalence Testing
eBook - PDF

Handbook of Bioequivalence Testing

  1. 1,007 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Handbook of Bioequivalence Testing

About this book

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m

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Yes, you can access Handbook of Bioequivalence Testing by Sarfaraz K. Niazi 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
2014
Print ISBN
9781482226379
eBook ISBN
9781482226386
Edition
2
Subtopic
Pharmacology

Table of contents

  1. Front Cover
  2. Other Books by the Author
  3. Contents
  4. List of Figures
  5. List of Tables
  6. Preface
  7. Acknowledgments
  8. Author
  9. Chapter 1: Historical Perspective on Generic Pharmaceuticals
  10. Chapter 2: Physicochemical Basis of Bioequivalence Testing
  11. Chapter 3: Drug Delivery Factors
  12. Chapter 4: Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling
  13. Chapter 5: Bioequivalence Testing Rationale and Principles
  14. Chapter 6: Bioequivalence Waivers
  15. Chapter 7: Statistical Evaluation of Bioequivalence Data
  16. Chapter 8: Regulatory Inspection Process
  17. Chapter 9: Fed Bioequivalence Studies
  18. Chapter 10: Topical Drugs
  19. Chapter 11: Bioequivalence of Nasal Products
  20. Chapter 12: Bioequivalence of Complimentary and Alternate Medicines
  21. Chapter 13: Bioequivalence of Biosimilar Products
  22. Chapter 14: Bioequivalence Testing : The U.S. Perspective
  23. Chapter 15: Bioequivalence Testing : European Perspective
  24. Chapter 16: Bioequivalence Testing : The ROW Perspective
  25. Chapter 17: Bioequivalence Testing Protocols
  26. Chapter 18: Bioequivalence Documentation
  27. Chapter 19: Good Laboratory Practices
  28. Chapter 20: Bioanalytical Method Validation
  29. Chapter 21: Good Clinical Practice
  30. Chapter 22: Computer and Software Validation
  31. Chapter 23: Outsourcing and Monitoring of Bioequivalence Studies
  32. Chapter 24: Epilog : Future of Bioequivalence Testing
  33. Appendix A: Glossary of Terms
  34. Appendix B: Dissolution Testing Requirements for U.S. FDA Submission
  35. Bibliography
  36. Back Cover