Results 81 to 90 of about 9,047 (170)
PharmaceuticalsBackground: Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first ...
Hao Ruan +6 more
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Journal of Pharmacy & Pharmaceutical Sciences, 2010 Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn.
Wai Ling Au +2 more
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Epilepsia, Volume 67, Issue 3, Page 1267-1283, March 2026.Abstract Objective A Pediatric Investigation Plan (PIP) implemented under the European Pediatric Regulation (EC No. 1901/2006) aims to ensure early and systematic evaluation of medicines for children. We analyze PIPs for antiseizure medications (ASMs) submitted to the European Medicines Agency (EMA) since 2006, characterizing their content, focusing on
Valeria Agostini, Stéphane Auvin
wiley +1 more source
Planning and evaluation of bioequivalence studies of rosuvastatin drug products
Регуляторные исследования и экспертиза лекарственных средств, 2018 The article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation.
D. P. Romodanovsky, D. V. Goryachev
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Frontiers in PharmacologyMost of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence.
Nedaa Alomari, Waleed Alhussaini
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PharmaceuticsAs the field of personalized dosing develops, the pharmaceutical manufacturing industry needs to offer flexibility in terms of tailoring the drug release and strength to the individual patient’s needs.
Olha Shuklinova +7 more
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Phentolamine bioequivalence study.
International journal of clinical pharmacology and therapeutics, 2004 To assess the bioequivalence of 2 tablet formulations of phentolamine (Regitine phentolamine 40 mg tablet formulation by Novartis, Brazil, as test formulation, and Vasomax, phentolamine 40 mg tablet formulation by Schering Plough S.A., Brazil, as reference formulation).A single 40 mg oral dose of each formulation was administered to 36 male healthy ...
Silva, LFG +5 more
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Citation: 'bioequivalence' in the IUPAC Compendium of Chemical Terminology, 5th ed.; International Union of Pure and Applied Chemistry; 2025. Online version 5.0.0, 2025. 10.1351/goldbook.15154 • License: The IUPAC Gold Book is licensed under Creative Commons Attribution-ShareAlike CC BY-SA 4.0 International for individual terms. Requests for commercial
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Highly variable medicines - specific aspects of bioequivalence studies
Регуляторные исследования и экспертиза лекарственных средств, 2018 At present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokinetic ...
D. P. Romodanovsky +6 more
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