Оценка эквивалентности in vitro генерических лекарственных средств кетопрофена
About the Author
Ю. КулиничRussian Federation
References
1. Проведение качественных ис- ледований биоэквивалентности лекар- твенных средств. Методические указа- ия / Под ред. В.Г.Кукеса, В.П.Фисенко. ., 2008. С. 34.
2. Guidance for Industry. Waiver of n vivo Bioavailability and Bioequivalence tudies for Immediate-Release Solid Oral osage Forms Based on a Biopharmaceutics lassification System. FDA, 2000.
3. WHO Technical Report Series 37, annex 8 «Proposal to waive in ivo bioequivalence requirements for HO Model List of Essential Medicines mmediate-release, solid oral dosage orms». WHO Expert Committee on pecificationsforPharmaceutical reparations, 2006.
4. M. Lindenberg, S. Kopp, J. ressman. Classification of orally dministered drugs on the World ealth Organization Model list of ssential Medicines according to the iopharmaceutics classification system // uropean Journal of Pharmaceutics and iopharmaceutics. 2004. Vol. 58, Issue 2. . 265-278.
Review
For citations:
. Journal Biomed. 2010;1(4):97-98. (In Russ.)