Navegando por Palavras-chave "bioequivalence"

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    Development and validation of a rapid and sensitive LC-ESI-MS/MS method for ondansetron quantification in human plasma and its application in comparative bioavailability study
    (Wiley-Blackwell, 2010-11-01) Moreira, Roberto F.; Salvadori, Myriam C.; Azevedo, Cristina P.; Oliveira-Silva, Diogo [UNIFESP]; Borges, Diego C.; Moreno, Ronlison A.; Sverdloff, Carlos E.; Borges, Ney C.; Universidade Estadual de Campinas (UNICAMP); ChromAnal MCM Anal Labs; Universidade Federal de São Paulo (UNIFESP); Fac Med; Synchrophar Assessora & Desenvolvimento Projetos
    The validation of a high throughput and specific method using a high-performance liquid chromatography coupled to electrospray (ES+) ionization tandem triple quadrupole mass spectrometric (LC-ESI-MS/MS) method for ondansetron quantification in human plasma is described Human plasma samples were extracted by liquid-liquid extraction (LLE) using methyl tert-butyl ether and analyzed by LC-ESI-MS/MS the limit of quantification was 0 2 ng/mL and the method was linear in the range 0 2-60 ng/mL the intra-assay precisions ranged from 1 6 to 7 7%, while inter-assay precisions ranged from 2 1 to 5 1% the intra-assay accuracies ranged from 97 5 to 108 2%, and the inter-assay accuracies ranged from 97 3 to 107 0% the analytical method was applied to evaluate the relative bioavailability of two pharmaceutical formulations containing 8 mg of ondansetron each in 25 healthy volunteers using a randomized, two-period crossover design the geometric mean and respective 90% confidence interval (Cl) of ondansetron test/reference percent ratios were 90 15% (81 74-99 44%) for C(max) and 93 11% (83 01-104 43%) for AUC(o-t) Based on the 90% confidence interval of the individual ratios (test formulation/reference formulation) for C(max) and AUC(o-inf), , it was concluded that the test formulation is bioequivalent to the reference one with respect to the rate and extent of absorption of ondansetron Copyright (C) 2010 John Wiley & Sons, Ltd
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    A fast and sensitive UHPLC-MS/ MS method for the determination of N-butylscopolamine in human plasma: application in a bioequivalence study
    (Wiley, 2017) Suenaga, Eunice Mayumi [UNIFESP]; Val, Ligia de Cassia; Tominaga, Mineko; Souza Filho, Jose Homero; Soares, Gidel; Vioto, Monalisa; Nakaie, Clovis Ryuichi [UNIFESP]
    We have developed and validated a fast and sensitive ultra high-performance liquid chromatography with positive ion electrospray ionization tandem mass spectrometry method for determining N-butylscopolamine levels in human plasma using propranolol as an internal standard.The acquisition was set up in the multiple reaction monitoring mode with the transitions m/ z 360.3.138.0 for N-butylscopolamine and m/ z 260.2.116.1 for IS.This method uses a liquid-liquid extraction process with dichloromethane.The analyte and IS were chromatographed on a C18, 50x2.1 mm, 1.7 mu m column through isocratic elution with acetonitrile- 5mM ammonium acetate (adjusted to pH 3.0 with formic acid).The method was linear in the 1-1000 pg/ mL range for N-butylscopolamine and was selective, precise, accurate and robust.The validated method was successfully applied to perform a bioequivalence study of the reference (Buscopan r, from Boehringer Ingelheim) and the test sample coated-tablet formulations (from Foundation for Popular Remedy), both containing 10 mg of N-butylscopolamine bromide administered as a single dose.Using 58 healthy volunteers and accounting for the high intra-individual variability confirmed by statistical calculations (38%), the two formulations were considered bioequivalent because the rate and extent of absorption (within 80-125% interval), satisfying international requirements.
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    Medicamentos genéricos no tratamento das epilepsias: uma reflexão
    (Liga Brasileira de Epilepsia (LBE), 2007-09-01) Yacubian, Elza Márcia Targas [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    OBJECTIVE: We discuss some controversial aspects with prescription of generic drugs (GD) and the problems concerning bioequivalence in the treatment of epilepsy. Some antiepileptic drugs (AED) are poorly soluble in water, have nonlinear kinetics and a narrow therapeutic range, implying that problems with bioequivalence are likely to occur. There are clearly advantages (cost saving) and disadvantages (loss of seizure control or drug toxicity) in prescribing generics AED. METHODS: Review of literature. RESULTS AND CONCLUSION: The main information is about classical AED (phenytoin, carbamazepine and valproate). Regarding the new AED we found only one poster presentation related to lamotrigine substitution. The level of evidence is, generally, weak, based on case-series and expert opinion without explicit critical appraisal (except in phenytoin with level of evidence moderate, based on some analytical studies). We may allow the use of generics for epilepsy treatment. However, this opens the possibility of successive substitution of different formulations which may even be life threatening.