Handbook of Bioequivalence Testing

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

• 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.