COMMENTARIES Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine Sulfate
نویسندگان
چکیده
Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand WHO—World Health Organization, Geneva, Switzerland University of Saskatchewan, Saskatoon, Saskatchewan, Canada International Pharmaceutical Federation FIP, The Hague, The Netherlands Pharmaceutics Division, College of Pharmacy, University of Texas at Austin, Austin, Texas Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt, Germany RIVM–National Institute for Public Health and the Environment, P.O. Box 1, Bilthoven 3720 BA, The Netherlands
منابع مشابه
Biowaiver monographs for immediate release solid oral dosage forms: ranitidine hydrochloride.
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Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing (biowaiver) for the approval of immediate release (IR) solid oral dosage forms containing aciclovir are reviewed. Aciclovir therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) studies were ...
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تاریخ انتشار 2009