Sarfaraz K. Niazi

Handbook of Bioequivalence Testing (eBook, PDF)

• Format: PDF

Produktbeschreibung

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 m

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 1007
• Erscheinungstermin: 29. Oktober 2014
• Englisch
• ISBN-13: 9781482226386
• Artikelnr.: 57081254

Autorenporträt

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.

Inhaltsangabe

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.