2nd Edition

Handbook of Bioequivalence Testing

By Sarfaraz K. Niazi Copyright 2015
    1007 Pages 39 B/W Illustrations
    by CRC Press

    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.

    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


    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.

    "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