کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2485689 | 1114364 | 2010 | 13 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Furosemide
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
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چکیده انگلیسی
Literature and new experimental 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 furosemide are reviewed. The available data on solubility, oral absorption, and permeability are sufficiently conclusive to classify furosemide into Class IV of the Biopharmaceutics Classification System (BCS). Furosemide's therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) problems are also taken into consideration. In view of the data available, it is concluded that the bio waiver procedure cannot be justified for either the registration of new multisource drug products or major postapproval changes (variations) to existing drug products. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:2544-2556, 2010
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 6, June 2010, Pages 2544-2556
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 6, June 2010, Pages 2544-2556
نویسندگان
G.E Granero, M.R. Longhi, M.J. Mora, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends,