دانلود کتاب Handbook of Bioequivalence Testing, Second Edition

فهرست مطالب :

Content: Front Cover; Other Books by the Author; Contents; List of Figures; List of Tables; Preface; Acknowledgments; Author; Chapter 1: Historical Perspective on Generic Pharmaceuticals; Chapter 2: Physicochemical Basis of Bioequivalence Testing; Chapter 3: Drug Delivery Factors; Chapter 4: Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling; Chapter 5: Bioequivalence Testing Rationale and Principles; Chapter 6: Bioequivalence Waivers; Chapter 7: Statistical Evaluation of Bioequivalence Data; Chapter 8: Regulatory Inspection Process; Chapter 9: Fed Bioequivalence Studies; Chapter 10: Topical Drugs Chapter 11: Bioequivalence of Nasal ProductsChapter 12: Bioequivalence of Complimentary and Alternate Medicines; Chapter 13: Bioequivalence of Biosimilar Products; Chapter 14: Bioequivalence Testing : The U.S. Perspective; Chapter 15: Bioequivalence Testing : European Perspective; Chapter 16: Bioequivalence Testing : The ROW Perspective; Chapter 17: Bioequivalence Testing Protocols; Chapter 18: Bioequivalence Documentation; Chapter 19: Good Laboratory Practices; Chapter 20: Bioanalytical Method Validation; Chapter 21: Good Clinical Practice; Chapter 22: Computer and Software Validation Chapter 23: Outsourcing and Monitoring of Bioequivalence StudiesChapter 24: Epilog : Future of Bioequivalence Testing; Appendix A: Glossary of Terms; Appendix B: Dissolution Testing Requirements for U.S. FDA Submission; Bibliography; Back Cover
Abstract: 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 made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revise