Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno

Gaete, Leonardo; G, Jaime Solís; F, Pablo Venegas; C, Mitzy J Carrillo; B, Oscar Schatloff; S, Iván Saavedra

doi:10.4067/s0034-98872003000500008

Cited by 2 publications

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“…Applying the methods suggested by the Food and Drug Administration (FDA) of the United States (90% confidence interval for the difference of log transformed mean pharmacokinetic parameters), the authors found these two presentations of risperidone to lack bioequivalence. 27 Crawford et al (1996) observed negative health benefit in approximately 10% of a sample of epilepsy patients after change of reference-medication to generic-medication, besides increased social costs. 28 However, some clinical studies in patients with epilepsy found no difference in efficacy between reference and generic drugs.…”

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confidence: 99%

Efficacy and safety of brand-risperidone versus similar-risperidone in elderly patients with neuropsychiatric disorders: A retrospective study

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et al. 2010

Dement. neuropsychol.

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To compare the efficacy and tolerability of brand-risperidone against similar-risperidone in elderly outpatients.MethodThe medical files of 16 elderly outpatients from the IPq-HCFMUSP treated with two formulations of risperidone (brand and similar) between July/1999 and February/2000 were reviewed. Two independent raters, using the Clinical Global Impression scale, evaluated the efficacy of the treatment with risperidone and the frequency of adverse effects.ResultsComparing October/1999 to November/1999, Rater 1 observed a trend (p=0.059) and Rater 2 found a statistically significant difference, in favor of the brand-risperidone group (p=0.014). Comparing October/1999 to February/2000, Rater 1 observed no statistically significant difference (p=0.190), but the Rater 2 found a statistically significant difference in favor of the brand-risperidone group (p=0.029). Comparing November/1999 to February/2000, both raters found no statistically significant differences between both risperidone formulations. Regarding adverse effects, a statistically significant difference (p=0.046) was found in favor of the patients treated with brand-risperidone.ConclusionsThe risperidone-reference, compared to similar-risperidone, showed a trend toward greater efficacy and tolerability.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of brand-risperidone versus similar-risperidone in elderly patients with neuropsychiatric disorders: A retrospective study

Folquitto

Barros

Pinto

et al. 2010

Dement. neuropsychol.

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“…uchile.cl L a biodisponibilidad (BD) de un fármaco es una medida de la cantidad y de la velocidad con que éste alcanza la circulación sistémica 1,2 . La bioequivalencia (BE) es una medida comparativa de la biodisponibilidad de una formulación farmacéutica, entre un producto similar y el producto innovador o referente del mercado 1,2 , en términos de la velocidad y cantidad de principio activo que entrega. Conociendo la calidad, seguridad y efi cacia de la formulación de un producto farmacéutico, el médico puede dis-poner de alternativas farmacéuticas a precios más convenientes para el paciente sin comprometer la efi cacia clínica y terapéutica 1,2 .…”

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“…La prescripción de un medicamento es el acto profesional realizado por un médico a través de la receta médica, en el entendido que su formación profesional le permite establecer cuál es la terapia adecuada para un determinado paciente. Por otra parte, la intercambiabilidad es el acto realizado por un médico de utilizar indistintamente una formulación u otra, disponiendo de elementos de juicio sufi cientes para asegurar que la calidad de uno de los productos farmacéuticos es comparable o similar a la del otro 2 .…”

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Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos

et al. 2011

Rev. méd. Chile

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Relative bioavailability study of two oral formulations of mycophenolate mofetil in healthy volunteers Background: The bioequivalence of different formulations of a same pharmaceutical product must be tested empirically. Aim: To evaluate the relative bioavailability for an oral formulation of mycophenolate mofetil (MMF) (Linfonex TM) compared to the reference formulation (Cellcept TM) to determine the bioequivalence between both formulations. Material and Methods: A randomized, crossover, double-blind trial in 22 healthy male volunteers, who received a single oral dose of 1000 mg of Linfonex and Cellcept with a washout period of 10 days. Plasma levels of the drug were determined by high performance liquid chromatography. Plasma concentrations were plotted and maximum concentration, area under the plasma concentration versus time between 0 and 12 hours after administration and area under plasma concentration curve versus time after administration between 0 and infi nity, were calculated for both products. Results: The active compound, mycophenolic acid, was similarly absorbed in both formulations. No statistically signifi cant differences were found in calculated pharmacokinetic parameters between both formulations. Conclusions: Linfonex TM 500 mg is bioequivalent to Cellcept TM 500 mg.

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Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno

Cited by 2 publications

References 0 publications

Efficacy and safety of brand-risperidone versus similar-risperidone in elderly patients with neuropsychiatric disorders: A retrospective study

Efficacy and safety of brand-risperidone versus similar-risperidone in elderly patients with neuropsychiatric disorders: A retrospective study

Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos

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