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References (11)
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(2008)
Fisenko, eds., Quality Investigations of Bioequivalency of drugs [in Russian
- Publisher
- Springer Journals
- Copyright
- Copyright © 2009 by Springer Science+Business Media, Inc.
- Subject
- Pharmacy; Organic Chemistry; Pharmacology/Toxicology ; Pharmacy
- ISSN
- 0091-150X
- eISSN
- 1573-9031
- DOI
- 10.1007/s11094-009-0337-5
- Publisher site
- See Article on Publisher Site
Abstract
At present the quality of generic drugs for registration in the Russian Federation is checked by studying their bioequivalence. According to FDA and WHO guidelines, some generic drugs can be registered on the basis of only in vitro data (dissolution test) without testing for the bioequivalence in vivo. A biowaiver procedure that is based on a biopharmaceutical classification system is developed for such a simplified registration scheme.
Journal
Pharmaceutical Chemistry Journal – Springer Journals
Published: Dec 3, 2009