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(2007)
Modern Regulatory Requirements for Investigation and Registration of Generic Drugs [in Russian], Farmsodruzhestvo
(2007)
Monographs on Biowaiver Based on Biopharmaceutical Classification [in Russian], WHO Prequalification
(2007)
Multisource (generic) drugs and their interchangeability [in Russian], WHO Prequalification
Michael Levin (2001)
Supac-Mr: Modified Release Solid Oral Dosage Forms—Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
O Baula (2007)
Modern Regulatory Requirements for Investigation and Registration of Generic Drugs
Joyce Parker (1985)
Book Reviews : Who Expert Committee on Specifications for Pharmaceutical Preparations. Published by World Health Organisation, 1984. Price: Sw. fr. 6. Paperback. Pp 54. ISBN: 924 120704 3The Journal of the Royal Society for the Promotion of Health, 105
Michael Levin (2001)
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
VP Shakh (2007)
Multisource (generic) drugs and their interchangeability
C. Becker, J. Dressman, G. Amidon, H. Junginger, S. Kopp, K. Midha, Vinod Shah, S. Stavchansky, D. Barends (2008)
Biowaiver monographs for immediate release solid oral dosage forms: ethambutol dihydrochloride.Journal of pharmaceutical sciences, 97 4
J Dressman, C Becker (2007)
Monographs on Biowaiver Based on Biopharmaceutical Classification
(2008)
Fisenko, eds., Quality Investigations of Bioequivalency of drugs [in Russian
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.
Pharmaceutical Chemistry Journal – Springer Journals
Published: Dec 3, 2009
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