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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-<FONT FACE=Symbol>¥</FONT> and the Cmax of MAA can be accurately predicted (R²>0.95, bias <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 |
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Velasque,L.S.; Estrela,R.C.E.; Suarez-Kurtz,G.; Struchiner,C.J.. |
Didanosine (ddI) is a component of highly active antiretroviral therapy drug combinations, used especially in resource-limited settings and in zidovudine-resistant patients. The population pharmacokinetics of ddI was evaluated in 48 healthy volunteers enrolled in two bioequivalence studies. These data, along with a set of co-variates, were the subject of a nonlinear mixed-effect modeling analysis using the NONMEM program. A two-compartment model with first order absorption (ADVAN3 TRANS3) was fitted to the serum ddI concentration data. Final pharmacokinetic parameters, expressed as functions of the co-variates gender and creatinine clearance (CL CR), were: oral clearance (CL = 55.1 + 240 x CL CR + 16.6 L/h for males and CL = 55.1 + 240 x CL CR for... |
Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Didanosine; Pharmacokinetics; NONMEM. |
Ano: 2007 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2007000100013 |
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