Consulta: subjectFacets:"Bioequivalence"
Registros recuperados: 3
Data/hora: 05/06/2024 14:14:39

Limited-sampling strategy models for estimating the pharmacokinetic parameters of 4-methylaminoantipyrine, an active metabolite of dipyrone
Provedor de dados: 56
Autores: Suarez-Kurtz,G.; Ribeiro,F.M.; Estrela,R.C.E.; Vicente,F.L.; Struchiner,C.J.
Bioanalytical data from a bioequivalence study were used to develop limited-sampling strategy (LSS) models for estimating the area under the plasma concentration versus time curve (AUC) and the peak plasma concentration (Cmax) of 4-methylaminoantipyrine (MAA), an active metabolite of dipyrone. Twelve healthy adult male volunteers received single 600 mg oral doses of dipyrone in two formulations at a 7-day interval in a randomized, crossover protocol. Plasma concentrations of MAA (N = 336), measured by HPLC, were used to develop LSS models. Linear regression analysis and a "jack-knife" validation procedure revealed that the AUC0-&lt;FONT FACE=Symbol&gt;¥&lt;/FONT&gt; and the Cmax of MAA can be accurately predicted (R²&gt;0.95, bias &lt;1.5%, precision...
Tipo: Info:eu-repo/semantics/article
Palavras-chave: Dipyrone; 4-methylaminoantipyrine; Limited-sampling models; Pharmacokinetics; Bioequivalence.
Ano: 2001
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2001001100017

Determination of Gemifloxacin in human plasma by high performance liquid chromatography using Ultra Violet detector and its application to a bioequivalence study
Provedor de dados: 60
Autores: Mousavi,Syed Husain Hashemi.
A liquid chromatography method was developed and validated for the determination of gemifloxacin in human plasma using chloramphenicol as internal standard to achieve lower quantification limit. Acetonitrile was used to precipitated and extracted analyte and internal standard from plasma by Protein Precipitation. Analysis was performed isocratically on C18 column using 25% acetonitrile and 75% 0.02 M phosphate buffer as mobile phase. The method was demonstrated to be linear from 0.003 µg/mL to 5 µg/mL with the lower limit of quantitation of 0.003 µg/mL. The method was successfully applied for the bioequivalence study of gemifloxacin after a single oral administration of 320 mg gemifloxacin mesylate tablets to 12 healthy volunteers.
Tipo: Info:eu-repo/semantics/article
Palavras-chave: Gemifloxacin/determination; Bioequivalence; Plasma; HPLC.
Ano: 2018
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000400610

Evaluation of the bioequivalence of two formulations containing the combination of 400 mg of acetaminophen (paracetamol), 4 mg of phenylephrine and 4 mg of chlorpheniramine in capsules: open-label, three-way crossover study, partially replicated in healthy volunteers of both sexes
Provedor de dados: 60
Autores: Santos,Alessandra Ferreira dos; Santos,Quevellin Alves dos; Correa,Carlos Eduardo Melo; Coelho,Edvaldo Capobiango.
This study was carried out in order to compare the relative bioavailability of two different formulations containing 400 mg of acetaminophen + 4 mg of phenylephrine hydrochloride + 4 mg of chlorpheniramine maleate, Test formulation (Cimegripe®) and Reference formulation (Resfenol®) in 84 healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 3-way and partially replicated. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical methods using the ultra-performance liquid chromatography coupled to tandem mass spectrometry. The Cmax, Tmax, AUC0-t,...
Tipo: Info:eu-repo/semantics/article
Palavras-chave: Acetaminophen; Phenylephrine; Chlorpheniramine; Bioequivalence; Partially replicated crossover; Ultra-high performance liquid chromatography; Mass spectrometry.
Ano: 2020
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502020000100564