Handbook of bioequivalence testing [electronic resource] / Sarfaraz K. Niazi.
Saved in:
| Online Access: |
Full Text (via Taylor & Francis) |
|---|---|
| Main Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Boca Raton, FL :
CRC Press,
©2015.
©20. |
| Edition: | 2nd ed. |
| Series: | Drugs and the pharmaceutical sciences ;
v. 213. |
| Subjects: |
MARC
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| 245 | 1 | 0 | |a Handbook of bioequivalence testing |h [electronic resource] / |c Sarfaraz K. Niazi. |
| 250 | |a 2nd ed. | ||
| 260 | |a Boca Raton, FL : |b CRC Press, |c ©2015. | ||
| 264 | 4 | |c ©20. | |
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| 490 | 1 | |a Drugs and the pharmaceutical sciences ; |v volume 213. | |
| 504 | |a Includes bibliographical references. | ||
| 505 | 0 | |a 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. | |
| 588 | 0 | |a Online resource; title from PDF title page (EBSCO, viewed December 11, 2014) | |
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| 776 | 0 | 8 | |i Print version: |a Niazi, Sarfaraz K. |t Handbook of Bioequivalence Testing, Second Edition. |d Hoboken : Taylor and Francis, ©2014 |z 9781482226379. |
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