Handbook of Bioequivalence Testing: 2nd Edition (Hardback) book cover

Handbook of Bioequivalence Testing

2nd Edition

By Sarfaraz K. Niazi

CRC Press

1,007 pages | 39 B/W Illus.

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Hardback: 9781482226379
pub: 2014-10-29
eBook (VitalSource) : 9780429156656
pub: 2014-10-29
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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 revised worldwide regulatory requirements.

New topics include:

  • A historical perspective on generic pharmaceuticals
  • New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications
  • Models of noninferiority
  • Biosimilarity of large molecule drugs
  • Bioequivalence of complementary and alternate medicines
  • Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies
  • New FDA guidelines for bioanalytical method validation
  • Outsourcing and monitoring of bioequivalence studies

The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.


"This handbook offers a complete description of every aspect of bioequivalence testing … [It] is an essential, one-of-a-kind resource for anyone interested in bioequivalence. There are no other books that compile so many aspects in one place."

—Jennifer L. Colon, PharmD, Temple University School of Pharmacy, in Doody’s Review Service

Table of Contents

Historical Perspective on Generic Pharmaceuticals

Physicochemical Basis of Bioequivalence Testing

Drug Delivery Factors

Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling

Bioequivalence Testing Rationale and Principles

Bioequivalence Waivers

Statistical Evaluation of Bioequivalence Data

Regulatory Inspection Process

Fed Bioequivalence Studies

Topical Drugs

Bioequivalence of Nasal Products

Bioequivalence of Complementary and Alternate Medicines

Bioequivalence of Biosimilar Products

Bioequivalence Testing: The US Perspective

Bioequivalence Testing: European Perspective

Bioequivalence Testing: The ROW Perspective

Bioequivalence Testing Protocols

Bioequivalence Documentation

Good Laboratory Practices

Bioanalytical Method Validation

Good Clinical Practice

Computer and Software Validation

Outsourcing and Monitoring of Bioequivalence Studies

Epilogue: Future of Bioequivalence Testing

Appendix A: Glossary of Terms

Appendix B: Dissolution Testing Requirements for US FDA Submission



About the Author

Sarfaraz K. Niazi, PhD, is the chairman and CEO of Therapeutic Proteins International, a world-class developer and manufacturer of biosimilar recombinant drugs. The company now leads the world in using innovative methods of manufacturing biosimilar recombinant drugs coming off-patents. He employs hundreds of world’s top scientists working toward the goal of making life-saving biological drugs more affordable. He has published over 100 refereed research articles and abstracts, dozens of books, and hundreds of literary writings that span the vast areas of poetry, philosophy, rhetoric, irony, and modern dilemma.

About the Series

Drugs and the Pharmaceutical Sciences

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Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
MEDICAL / Pharmacy
SCIENCE / Chemistry / General