Bioequivalence Study
Mostrando 13-24 de 53 artigos, teses e dissertações.
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13. Estudo de farmacocinetica comparativa de uma formulação de amlodipina + maleato de enalapril versus uma formulação de amlodipina e versus uma formulação de maleato de enalapril em voluntarios sadios de ambos os sexos / Comparative pharmacokinetics study of a formulation of amlodipine + enalapril versus an enalapril maleate formulation in healthy volunteers of both genders
Introduction: Based on evidence of studies showing that in 2/3 of the cases of hypertension monotherapy is not enough to reach pressure reduction and facing the necessity of a more rigorous control, there is a clear current trend to the early introduction of a combined therapy of anti-hypertensive drugs as first pharmacological measure. These associations of
Publicado em: 2009
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14. Correlação in vitro in vivo para formas farmacêuticas sólidas de liberação modificada contendo diclofenaco de sódio / In vitro-in vivo correlation for sodium diclofenac modified release tablet formulations
The term in vitro-in vivo correlation (IVIVC) refers to the establishment of a rational relationship between the biological properties, or a parameter derived from a biological property produced by a dosage form, and a physicochemical characteristic or property of the same dosage form. The establishment of IVIVC enables the substitution of in vivo studies fo
Publicado em: 2009
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15. Desenvolvimento de métodos analíticos para quantificação de artemeter e lumefantrina em comprimidos de dose fixa combinada e em plasma humano.
Nowadays, malaria is the worlds most incident parasitic infection. The artemisinin based combination therapy (ACT) has been advocated as a promising treatment for malaria and artemetherlumefantrine (20+120 mg) is the main recommended association in endemic areas. In spite of the wide use of this association, the scientific literature is still scarce regardin
Publicado em: 2009
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16. Reversed phase HPLC determination of tamoxifen in dog plasma and its pharmaco-kinetics after a single oral dose administration
The analytical method developed to evaluate tamoxifen in dog plasma samples was precise, accurate, robust and linear in the range of 5-200 ng/mL. The limits of detection and quantification were 0.981 ng/mL and 2.97 ng/mL, respectively. Besides, the intra-day precision and accuracy variations were 8.78 and 10.16%, respectively. Tamoxifen concentrations were a
Química Nova. Publicado em: 2008
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17. 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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18. Bioequivalence study of two formulations with 2 mg of cyproterone acetate and 0,35 mg ethynilestradiol in healthy volunteers by high-performance liquid coupled to mass spectrometry / Estudo de bioequivalencia entre duas formulações contendo 2 mg de acetato de ciproterona e 0,035 mg de etinilestradiol em voluntarias sadias atraves de cromatografia liquida acoplada a espectrometria de massas
O objetivo deste estudo foi avaliar a bioequivalência de duas formulações de acetato de ciproterona e etinilestradiol em drágea vs comprimido (Selene® comprimidos, Laboratório Eurofarma Ltda., formulação Teste e Diane® 35, Schering do Brasil, como Referência) após administração oral em 48 voluntárias adultas sadias. O estudo foi do tipo aberto,
Publicado em: 2008
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19. Effectiveness of highly active antiretroviral therapy using non-brand name drugs in Brazil
In Brazil, HIV-infected individuals receive drugs (including non-brand name drugs which comprise locally produced generics and drugs that have not been tested in bioequivalence trials) free of charge from the government. The objective of the present study was to evaluate the effectiveness of highly active antiretroviral therapy (HAART) in Rio de Janeiro, Bra
Brazilian Journal of Medical and Biological Research. Publicado em: 2007-04
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20. Lithium carbonate: atomic absortion spectrophotometry in bioequivalence and pediatric pattern of use. / Carbonato de lítio: utilização da espectrofotometria de absorção atômica em bioequivalência e perfil de uso na pediatria.
The ideal of this thesis is to benefit patients that use lithium, through two studies: (1) comparison of the bioavailability of two lithium formulations; and (2) investigation of lithium use in children and adolescents. In order to analyze the bioequivalence, healthy volunteers (N=24), of both genders, were treated with two lithium carbonate formulations (30
Publicado em: 2007
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21. Determination of chlorpropamide in plasma, using high-performance liquid chromatography coupled to tandem mass spectrometry (LC/MS/MS) and their application in a study of bioequivalence / Determinação de clorpropamida em plasma empregando empregando cromatografia liquida de alta eficiencia acoplada a espectrometria de massa sequencial (LC/MS/MS) e sua aplicação em um estudo de bioequivalencia
The relative bioavailability between two formulations of chlorpropamide was assessed on the dosage form tablet 250 mg, in healthy volunteers of both sexes. The study was conducted using an open, randomized, two-period crossover design with the 3-week washout interval. Thirty-six subjects were selected. The blood samples were collected at the time prior to do
Publicado em: 2007
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22. Desenvolvimento e validaÃÃo de mÃtodos bionalÃticos para dosagem de antimicrobianos em plasma humano
The Brazilian policy for generic drugs (Bill n 9.787, 10th of February, 1999) is improving the access to quality medicines by the Brazilian population. However, it makes it necessary to have analytical methods for the quantification of drugs in biological matrices with better selectivity and sensitivity for both drugs and metabolites so that they can be ap
Publicado em: 2007
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23. Avaliação da bioequivalência de comprimidos contendo 10 mg de cloridrato de ciclobenzaprina / Bioequivalence avaliation of tables contain 10 mg of cyclobenzaprine hydrochloride
Cyclobenzaprine is a centrally acting muscle relaxant that has similarity with a tricyclic antidepressant. The purpose of this study was to evaluate the bioequivalence of two brands of cyclobenzaprine 10 mg tablets in healthy volunteers. The procedure of bioequivalence between test product (Miosan®) and reference product (Flexeril®) was a randomized, open
Publicado em: 2006
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24. Estudo de bioequivalencia entre duas formulações de oxcarbazepina de 600mg em voluntarios sadios de ambos os sexos / Bioequivalence study between two 600mg oxcarbazepine formulations in health volunteers of both genders
The purpose of this study was to compare the bioavailability of two oxcarbazepine formulations in 600mg pills - a test formulation produced by Cristália Produtos Químicos Farmacêuticos Ltda with the Trileptal® formulation by Novartis Pharma. Based on the low interindividual variability of this drug and the existing bibliography, the study sample size ind
Publicado em: 2006