Highly Variable Drugs: Experience with Propafenone

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Table of Contents
  1. Highly Variable Drugs: Experience with Propafenone
  2. Highly Variable Drugs
  3. What Is Bioequivalence?
  4. Criteria For Bioequivalence
  5. Propafenone
  6. Bioequivalence Of Propafenone Tablets
  7. Cont’d
  8. Mean Plasma Concentrations
  9. Results
  10. Plasma Profiles From Two Subjects
  11. Results - Cont’d
  12. Reasons For Failure
  13. Inter-subject Variability
  14. Sources Of Variability
  15. Sources Of Variability - Cont’d
  16. Re-analysis Of BE Data
  17. Proof Of High Variability
  18. What is n for demonstrating BE With CV = 29%?
  19. Bioequivalence Standards: Do We Have The Right Balance?
  20. What Is The Right Balance?
  21. Acknowledgement

JPPS 1(2) Table of Contents

Author: Dr. Y. Tsang
Email: ytsang@Apotex.CA
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