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
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.
"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
