Bioequivalence Study Simulation
Mostrando 1-4 de 4 artigos, teses e dissertações.
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1. Evaluation of the effects on different doses and sampling schedules on the assessment of bioequivalence / Avaliação de diferentes cronogramas de coletas de amostras biológicas em estudos de bioequivalência e análise da influência de teor de fármaco sobre os resultados destes estudos
Os estudos de bioequivalência são realizados em humanos, por meio da administração dos medicamentos em estudo pela mesma via extravascular, sob condições experimentais padronizadas, seguida pela determinação das concentrações plasmáticas do fármaco em função do tempo. Nestes estudos considera-se que curvas estatisticamente semelhantes de decaim
Publicado em: 2008
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2. Intervalo de confiança para avaliação de bioequivalencia individual utilizando a medida de Kullback-Leibler
Bioequivalence trials are conducted to show that two formlllations, a reference dmg R and a test T, produces similar bioavailabitity. In Brazil, the introduction of the generic drug started in 1999 and the current analysis of the pharmacokinetics measures for rate and extent of the absorption is the average bioequivalence (ABE) which is not sufficient to gua
Publicado em: 2004
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3. Limited-sampling strategy models for estimating the pharmacokinetic parameters of 4-methylaminoantipyrine, an active metabolite of dipyrone
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
Brazilian Journal of Medical and Biological Research. Publicado em: 2001-11
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4. An Investigation into the Importance of “Very Rapid Dissolution” Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology
The Biopharmaceutics Classification System (BCS) is based on the mechanistic assumptions that the rate and extent of oral drug absorption are governed by drug solubility, intestinal permeability, and dissolution rate from the dosage form administered. One of the goals of BCS is to identify classes of drugs for which bioequivalence may be established based so
Springer US.