COMMENTARY Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ethambutol Dihydrochloride
نویسندگان
چکیده
C. BECKER, J.B. DRESSMAN, G.L. AMIDON, H.E. JUNGINGER, S. KOPP, K.K. MIDHA, V.P. SHAH, S. STAVCHANSKY, D.M. BARENDS Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main, Germany College of Pharmacy, University of Michigan, Ann Arbor, Michigan Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand World Health Organization, Geneva, Switzerland University of Saskatchewan, Saskatoon, Saskatchewan, Canada International Pharmaceutical Federation FIP, Den Haag, The Netherlands Division of Pharmaceutics, College of Pharmacy, University of Texas at Austin, Austin, Texas RIVM—National Institute for Public Health and the Environment, Bilthoven, The Netherlands
منابع مشابه
Biowaiver monographs for immediate release solid oral dosage forms: ethambutol dihydrochloride.
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing ethambutol dihydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ethambutol dihydrochloride is a Biopharmaceutics Classification System (BCS) Class III drug with permeability properties approach...
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