Handbook of bioequivalence testing
tarafından
Niazi, Sarfaraz, 1949, author.
Başlık
:
Handbook of bioequivalence testing
Yazar
:
Niazi, Sarfaraz, 1949, author.
ISBN
:
9781482226386
Basım Bilgisi
:
Second edition.
Fiziksel Tanımlama
:
1 online resource
Seri
:
Drugs and the pharmaceutical sciences ; Volume 213
Drugs and the pharmaceutical sciences ; Volume 213.
İçerik
:
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.
Konu Terimleri
:
Drugs -- Therapeutic equivalency -- Handbooks, manuals, etc.
Elektronik Erişim
:
| Kütüphane | Materyal Türü | Demirbaş Numarası | Yer Numarası | [[missing key: search.ChildField.HOLDING]] | Durumu/İade Tarihi |
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| Çevrimiçi Kütüphane | E-Kitap | 546106-1001 | RM301.45 .N53 2015 | | CRC E-Books |