Title Handbook of bioequivalence testing / Sarfaraz K. Niazi

Edition 2nd ed Published Boca Raton, FL : CRC Press, ©2015 ©20

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Description 1 online resource Series Drugs and the pharmaceutical sciences ; volume 213 Drugs and the pharmaceutical sciences ; v. 213 Contents Chapter 1. Historical perspective on generic pharmaceuticals -- chapter 2. Physicochemical basis of bioequivalence testing -- chapter 3. Drug delivery factors -- chapter 4. Pharmacokinetic/pharmacodynamic (PK/PD) modeling -- chapter 5. Bioequivalence testing rationale and principles -- chapter 6. Bioequivalence waivers -- chapter 7. Statistical evaluation of bioequivalence data -- chapter 8. Regulatory inspection process -- chapter 9. Fed bioequivalence studies -- chapter 10. Topical drugs -- chapter 11. Bioequivalence of nasal products -- chapter 12. Bioequivalence of complimentary and alternate medicines -- chapter 13. Bioequivalence of biosimilar products -- chapter 14. Bioequivalence testing : the U.S. perspective -- chapter 15. Bioequivalence testing : European perspective -- chapter 16. Bioequivalence testing : the ROW perspective -- chapter 17. Bioequivalence testing protocols -- chapter 18. Bioequivalence documentation -- chapter 19. Good laboratory practices -- chapter 20. Bioanalytical method validation -- chapter 21. Good clinical practice -- chapter 22. Computer and software validation -- chapter 23. Outsourcing and monitoring of bioequivalence studies -- chapter 24. Epilog : future of bioequivalence testing Bibliography Includes bibliographical references Notes Online resource; title from PDF title page (EBSCO, viewed December 11, 2014) Subject Drugs -- Therapeutic equivalency -- Handbooks, manuals, etc Drugs -- Therapeutic equivalency. Therapeutic Equivalency Drug Approval Models, Statistical MEDICAL -- Pharmacology. Drugs -- Therapeutic equivalency Médicaments génériques. United States Genre/Form Electronic books handbooks. Handbooks and manuals Handbooks and manuals. Guides et manuels. Form Electronic book ISBN 9781482226386 1482226383

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