Handbook of Bioequivalence Testing

by Niazi; Sarfaraz K.

• ISBN13: 9780849303951
• ISBN10: 0849303958
• Edition: 1st
• Format: Hardcover
• Copyright: 2007-08-22
• Publisher: CRC Press

Summary

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing covers all aspects of conducting these studies based on these newer requirements and the expectations of the regulatory agencies.

Author Biography

Sarfaraz K. Niazi is Chief Executive Officer, Pharmaceutical Scientist Inc., Deerfield, Illinois.

Table of Contents

Preface	p. v
Tables and figures	p. xi
Bioequivalence Testing Rationale and Principles	p. 1
Regulatory Aspects of Bioequivalence Testing	p. 45
Pharmacokinetic and Pharmacodynamic Modeling	p. 61
Waiver of Bioavailability/Bioequivalence Studies	p. 69
Regulatory Review Process	p. 89
Statistical Evaluation of Bioequivalence Data	p. 119
Physicochemical Properties Affecting Bioequivalence	p. 163
Drug Delivery Factors	p. 197
Bioanalytical Method Validation	p. 237
Good Clinical Practice	p. 265
Good Laboratory Practices for Nonclinical Laboratory Studies	p. 295
Computer and Software Validation	p. 317
Bioequivalence Reports	p. 339
Glossary of Terms	p. 443
Bioequivalence Testing Literature	p. 461
Dissolution Testing Methods of Approved Drugs	p. 535
Index	p. 553
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