Handbook of Bioequivalence Testing

Sarfaraz K. Niazi

• Publisher: CRC Press
• Year: 2014
• eBook ISBN:
  9781040173732
• Topic: Medicine
• Subtopic: Pharmacology

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

Table of contents

• Cover Page
• Halftitle Page
• DRUGS AND THE PHARMACEUTICAL SCIENCES
• Title Page
• Copyright Page
• Dedication Page
• About the Author
• Contents
• List of Figures
• List of Tables
• Preface
• Acknowledgments
• Author
• 1 Historical Perspective on Generic Pharmaceuticals
• 2 Physicochemical Basis of Bioequivalence Testing
• 3 Drug Delivery Factors
• 4 Pharmacokinetic/ Pharmacodynamic (PK/PD) Modeling
• 5 Bioequivalence Testing Rationale and Principles
• 6 Bioequivalence Waivers
• 7 Statistical Evaluation of Bioequivalence Data
• 8 Regulatory Inspection Process
• 9 Fed Bioequivalence Studies
• 10 Topical Drugs
• 11 Bioequivalence of Nasal Products
• 12 Bioequivalence of Complimentary and Alternate Medicines
• 13 Bioequivalence of Biosimilar Products
• 14 Bioequivalence Testing The U.S. Perspective
• 15 Bioequivalence Testing European Perspective
• 16 Bioequivalence Testing The ROW Perspective
• 17 Bioequivalence Testing Protocols
• 18 Bioequivalence Documentation
• 19 Good Laboratory Practices
• 20 Bioanalytical Method Validation
• 21 Good Clinical Practice
• 22 Computer and Software Validation
• 23 Outsourcing and Monitoring of Bioequivalence Studies
• 24 Epilog
• Appendix A: Glossary of Terms
• Appendix B: Dissolution Testing Requirements for U.S. FDA Submission
• Bibliography
• Index