Library of American University of Madaba
Handbook of bioequivalence testing /
by Niazi, Sarfaraz,
Series: Drugs and the pharmaceutical sciences ; . vol. 213 Published by : CRC Press, (Boca Raton, FL :) Physical details: li, 955 p. : ill. ; 26 cm. ISBN: 1482226375 Subject(s): Drugs %Therapeutic equivalency %Handbooks, manuals, etc. | Therapeutic Equivalency %United States. | Drug approval %United States. | Models, Statistical %United States. | Therapeutic Equivalency %United States. | Models, Statistical %United States. | Drugs %Therapeutic equivalency. | Médicaments génériques. | Handbooks, manuals, etc. Year: 2015| Item type | Location | Call Number | Status | Date Due |
|---|---|---|---|---|
 Book |
AUM Main Library | 615.1 N577 (Browse Shelf) | Available |
Includes bibliographical references and index.
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.
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