Handbook of Bioequivalence Testing by Sarfaraz K. Niazi (English) Hardcover Book

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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 pharmaceuticalsNew guidelines governing submissions related to bioequivalency studies, along with therapeutic code classificationsModels of noninferiority Biosimilarity of large molecule drugsBioequivalence of complementary and alternate medicinesBioequivalence of biosimilar therapeutic proteins and monoclonal antibodiesNew FDA guidelines for bioanalytical method validationOutsourcing and monitoring of bioequivalence studiesThe 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.

FORMATHardcover LANGUAGEEnglish CONDITIONBrand New Author Biography

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.

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. Bibliography. Index.

Review

"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

Review Quote

"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

Details ISBN1482226375 Author Sarfaraz K. Niazi Year 2014 ISBN-10 1482226375 ISBN-13 9781482226379 Format Hardcover Pages 1007 Edition 2nd Replaces 9780849303951 DEWEY 615.19 Birth 1949 Short Title HANDBK OF BIOEQUIVALENCE TESTI Language English Media Book Affiliation Pharmaceutical Scientist Inc., Deerfield, Illinois, USA Publication Date 2014-10-29 UK Release Date 2014-10-29 Illustrations 116 Tables, black and white; 39 Illustrations, black and white Edition Description 2nd edition Series Drugs and the Pharmaceutical Sciences Audience Tertiary & Higher Education Publisher Taylor & Francis Inc Imprint CRC Press Inc Place of Publication Bosa Roca Country of Publication United States US Release Date 2014-10-29 We've got this

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