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Id: biblio-1039229
Autor: Ordóñez, Karen; Feinstein, Max M; Reyes, Sergio; Hernández-Gómez, Cristhian; Pallares, Christian; Villegas, María V.
Título: Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia
Fonte: Braz. j. infect. dis;23(4):237-245, July-Aug. 2019. tab, graf.
Idioma: en.
Resumo: Abstract Background: Recent studies suggest that sustained use of generic antibiotics may be associated with clinical failure and emergence of antibacterial resistance. The present study was designed to determine the clinical outcome between the use of generic meropenem (GM) and brand-name meropenem (BNM). Additionally, this study evaluated the economic impact of GM and BNM to determine if the former represents a cost-effective alternative to the latter. Methods: Patients treated between January 2011 and May 2014 received GM while patients treated between June 2014 and March 2017 received BNM. Mortality was compared between groups. Total infection cost was defined by the cost of antimicrobial consumption, length of stay, and laboratory and imaging exams until infection resolution. Findings: A total of 168 patients were included; survival rate for the 68 patients treated with GM was 38% compared to 59% in the patients treated with BNM. Multivariate analysis showed that the variables most strongly-associated with mortality were cardiovascular disease (OR 18.18, 95% CI 1.25-262.3, p = 0.033) and treatment with generic meropenem (OR 18.45, 95% CI 1.45-232.32, p = 0.024). On the other hand, total infection cost did not show a significant difference between groups (BNM $10,771 vs. GM $11,343; p = 0.91). Interpretation: The present study suggests that patients treated with GM have a risk of death 18 times higher compared to those treated with BNM. Furthermore, economic analysis shows that GM is not more cost effective than BNM. Summary: More studies measuring clinical outcomes are needed to confirm the clinical equivalence of brand-name versus generic antibiotics, not only for meropenem but also for other molecules.
Descritores: Medicamentos Genéricos/economia
Medicamentos Genéricos/uso terapêutico
Meropeném/economia
Meropeném/uso terapêutico
Unidades de Terapia Intensiva/economia
Antibacterianos/economia
Antibacterianos/uso terapêutico
-Modelos Logísticos
Análise de Sobrevida
Análise Multivariada
Fatores de Risco
Resultado do Tratamento
Infecções por Bactérias Gram-Negativas/mortalidade
Infecções por Bactérias Gram-Negativas/tratamento farmacológico
Análise Custo-Benefício
Distribuição por Sexo
Colômbia
Distribuição por Idade
Centros de Atenção Terciária/estatística & dados numéricos
Limites: Humanos
Masculino
Feminino
Adolescente
Adulto
Pessoa de Meia-Idade
Idoso
Adulto Jovem
Responsável: BR1.1 - BIREME


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Id: lil-517997
Autor: Sarasqueta, Pedro de.
Título: Los medicamentos en el marco de la crisis / Drugs in the context of crisis
Fonte: Med. infant;9(1):3-4, mar. 2002.
Idioma: es.
Descritores: Atenção Primária à Saúde
Comercialização de Medicamentos
Medicamentos Genéricos
Tipo de Publ: Editorial
Responsável: AR94.1 - Centro de Información Pediatrica


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Id: biblio-1127082
Autor: González, Francisca; González, Fernando.
Título: Estimación del ahorro hospitalario con el reemplazo de inmunosupresores genéricos en trasplante renal / Cost savings after switching from innovative tacrolimus to a generic version of the drug in transplant recipients
Fonte: Rev. méd. Chile;148(4):429-435, abr. 2020. tab, graf.
Idioma: es.
Resumo: Background The use of narrow therapeutic index generic immunosuppressant in solid organ transplantation is controversial. Most experiences switching to these drugs have short term follow-up periods, analyze only pharmacokinetic issues and do not systematically include either complications or cost analyses. Aim To analyze the costs and benefits of switching our kidney transplant recipients from innovative tacrolimus to a generic version of the drug. Material and Methods Fifty-seven stable transplant recipients were switched from innovative tacrolimus to a generic version of the drug, maintaining the same dose. They were followed for eight months recording all events during such period. Results We observed two infectious episodes, five allograft biopsies were performed and two patients had acute rejections. Conclusions From the payer's perspective, if all the costs associated with the change to generic tacrolimus are considered, savings related to a lower cost of the drug translate in a real financial loss for the public health system. The analysis also showed that frequent switches, even from one generic drug to a cheaper one is an even worse strategy to save money.
Descritores: Transplantados
-Tacrolimo
Medicamentos Genéricos
Redução de Custos
Rejeição de Enxerto
Imunossupressores
Limites: Humanos
Responsável: CL1.1 - Biblioteca Central


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Id: lil-742457
Autor: Silva Filho, Euclides Quintino da; Aguiar, José Luiz Neves de; Albert, André Luis Mazzei; Nobrega, Armi Wanderley.
Título: Estudo das propriedades físico-químicas da glibenclamida e excipientes que influem sobre resultados do ensaio de dissolução para medicamento similar e genérico / Effect of the physicochemical properties of glyburide on the results of dissolution test for generic and similar drugs
Fonte: Rev. Inst. Adolfo Lutz;72(4):316-321, 2013. ilus, tab, graf.
Idioma: pt.
Resumo: Alguns insumos farmacêuticos ativos (IFA) possuem como característica, a possibilidade de apresentarem o polimorfismo, que pode se desenvolver em alguma das etapas do processo de produção na indústria. No caso deste não ser caracterizado e especificado, um diferente polimorfo poderá ser utilizado equivocadamente durante o processo de fabricação. A ocorrência de polimorfismo pode originar importantes variações nas propriedades físico-químicas dos IFAs, principalmente quanto à solubilidade. Alguns medicamentos de glibenclamida (GLIB) apresentaram denúncias de ineficácia terapêutica e a presença de polimorfos pode ser uma das possíveis causas. Neste trabalho foram analisados cinco medicamentos e cinco IFAS de diferentes fornecedores. Para os medicamentos foram feitos testes característicos de verificação de equivalência farmacêutica. Nos IFAS, as diversas técnicas empregadas não evidenciaram presença de polimorfos ou alterações importantes nas propriedades físico-químicas e na velocidade de dissolução intrínseca. Entretanto, os perfis de dissolução dos medicamentos, principalmente, entre os dois similares A e B demonstraram diferenças apontadas pelos valores do fator f2, respectivamente, de 20 e 42, os quais indicaram associação destes valores com a presença de distintos excipientes, como por exemplo o manitol e diferentes processos de produção industrial.

Some active pharmaceutical ingredients (API) might present polymorphism at any stage of the industryproduction process. In caseit is not characterized and specified, a different polymorph might beerroneously used during the manufacturing procedure. Polymorphisms cause some variations in thephysicochemical properties of APIs, especially in solubility. Therapeutic inefficacy was detected in someglyburide drug products, and the occurrence of polymorphs might be one of the possible reasons. Thisstudy analyzed five drug products and five APIs., The characteristic pharmaceutical equivalence testswere used for analyzing the drug products. The techniques employed to evaluate the APIs showed nodifferences in polymorphism, no significant changes in the physicochemical properties or in the intrinsicdissolution rate. However, the dissolution profiles of the drug products, mainly between two similarproducts A and B, showed significant differences in the f2 factor values, being 20 and 42, respectively,indicating that these values were related to the occurrence of different excipients, such as mannitol.
Descritores: Dissolução
Glibureto/análise
Insumos Farmacêuticos
Medicamentos Genéricos
Medicamentos Similares
-Cristalização
Responsável: BR91.2 - Centro de Documentação


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Id: lil-564550
Autor: Álvarez-Falconí, Pedro P.
Título: Derechos humanos en política de medicamentos: perfiles fundamentales / Human rights in drug policy: fundamental profiles
Fonte: Rev. peru. med. exp. salud publica;26(4):563-572, oct.-dic. 2009.
Idioma: es.
Resumo: Se revisan los conceptos que fundamentan los derechos humanos (DDHH), desde la perspectiva del iusnaturalismo. Los DDHH, que emanan del derecho natural, es el conjunto de atributos del hombre que derivan de su naturaleza humana,de su vida, que le permiten razonar, ser digno, autónomo, libre, con salud, tener un lenguaje, expresar manifestaciones artísticas y religiosas, con respeto hacia otras personas y a su persona, dentro de la cultura del grupo al que pertenece.Los DDHH están ligados a la vida, a la atención de salud y, ésta, al acceso de medicamentos, al estar amparado por la Constitución. Los medicamentos deben ser eficaces, inocuos y de calidad, con reposiciones oportunas, y los programas estar a cargo de funcionarios eficientes. Se discute sobre los DDHH y aspectos éticos en varias etapas de la historia.Se explora lo concerniente a los ensayos clínicos para el estudio de medicamentos innovadores, el contenido ético de documentos como la Declaración Universal de los Derechos Humanos, el Código de Nuremberg, la Declaración deHelsinki, la opinión de la Confederación Médica Latinoamericana y del Caribe respecto a modificaciones que afectaríanla salud de los probandos. Se hace referencia a los medicamentos esenciales o genéricos e innovadores. Es vista la jurisprudencia y decisiones respecto a patentes de medicamentos en algunos países de la región, las experiencias peruanas en el ámbito educativo y su proyección futura, opiniones de ecónomos y la importancia de los genéricos. Unapolítica de medicamentos, debe cautelar los DDHH respecto a la vida y la salud.

The concepts that are the basis of the human rights (HHRR) are revised from the perspective of the iusnaturalism. HHRR are originated from the natural right, and are the group of attributes of men that are derived from his human nature, his life, that allow him to reason, be worthy, autonomous, free , in good health, have a language, express artistic and religiousmanifestations, showing due respect to other people and himself, inside the culture of the group to which he belongs. HHRR are linked to life, to health assistance , and on turn, to drug access, as it is contemplated in the Constitution. Drugs must be efficacious, safe and of high quality, must be replaced on time and the programs must be driven by efficientmanagers. We discuss about the HHRR and ethical aspects in many stages of history. We explore clinical trials for the study of innovating drugs, the ethical contents of documents such as the Universal Declaration of Human Rights, the Nuremberg Code, the Helsinki Declaration, the opinion of the Medical Confederation of Latin-America and the Caribbean regarding modifications that would affect the health of the study subjects. We refer to essential or generic drugs and novel drugs. We revise the law system and decisions concerning the drug patents in some countries of the region, peruvian experiences in the educational field and their future projections, opinions from economists and the relevance of generic drugs. A drug policy must care for the HHRR regarding life and health.
Descritores: Declaração de Helsinki
Direitos Humanos
Ensaios Clínicos como Assunto
Medicamentos Genéricos
Ética
Limites: Humanos
Responsável: PE1.1 - Oficina Universitária de Biblioteca


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Id: lil-564549
Autor: Laosa, Olga; Guerra, Pedro; López-Durán, José Luis; Mosquera, Beatriz; Frías, Jesús.
Título: Estudios de bioequivalencia: la necesidad de establecer la fiabilidad de los medicamentos genéricos / Bioequivalence studies: need for the reability of generic drugs
Fonte: Rev. peru. med. exp. salud publica;26(4):553-562, oct.-dic. 2009. tab, graf.
Idioma: es.
Resumo: Un medicamento genérico es un medicamento que contiene un principio activo ya conocido y previamente desarrollado e inventado por otros. El coste de estos productos genéricos o multifuente debe ser menor que el de sus contrapartidasoriginales. Los efectos clínicos y el balance riesgo-beneficio de un medicamento no dependen exclusivamente de la actividadfarmacológica de la sustancia activa. La demostración de bioequivalencia de los medicamentos genéricos es de gran importancia. En Europa y en los Estados Unidos de Norteamérica la autorización de medicamentos genéricos descansa en la demostración de la bioequivalencia mediante estudios de biodisponibilidad comparada in vivo. Estos argumentos son imprescindibles para la autorización de la comercialización de los fármacos genéricos por parte de las autoridadessanitarias europeas y norteamericanas. Como medida de la cantidad de fármaco absorbido se utiliza el área bajo la curvaconcentración-tiempo (AUC), y como indicador de la velocidad de absorción se mide la concentración máxima (Cmax) alcanzada en la curva concentración-tiempo y el tiempo que tarda en alcanzarse (Tmax). Se entiende por bioequivalencia entre dos productos cuando presentan una biodisponibilidad comparable en condiciones experimentales apropiadas. El objetivo final de todo este proceso tiene como único sentido poner a disposición de la sociedad fármacos de calidad, que además puedan contribuir a una utilización más racional de los recursos económicos en el sistema sanitario.

A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. Theclinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the UnitedStates generic medicine approval is based in the demonstration of bioequivalence through comparative bioavailability studies in vivo. These arguments are required for marketing approval of generic medicines by the European and North American health authorities. As a measure of the amount of drug absorbed it is used the area under the curve concentrationtime (AUC), and as an indicator of the rate of absorption it is measured the peak concentration (Cmax) reached in the concentration-time curve and the time for its occurrence (Tmax). It is known as bioequivalence between two products when they have a comparable bioavailability in the appropriate experimental conditions. The ultimate goal of this process is to make quality drugs available to society and contribute to a more rational use of economic resources in the health system.
Descritores: Ensaios Clínicos como Assunto
Equivalência Terapêutica
Medicamentos Genéricos
Política de Medicamentos Genéricos
Área Sob a Curva
Limites: Humanos
Responsável: PE1.1 - Oficina Universitária de Biblioteca


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Id: lil-564545
Autor: Llamoza, Javier.
Título: Tratados comerciales y acceso a medicamentos en el Perú / Trade agreements and access to drugs in Peru
Fonte: Rev. peru. med. exp. salud publica;26(4):530-536, oct.-dic. 2009.
Idioma: es.
Resumo: A través de los tratados de libre comercio las economías de Estados Unidos de Norteamérica (EEUU) y la Unión Europea (UE) vienen consiguiendo un estándar más elevado de protección de los derechos de propiedad intelectual que amplíanindebidamente los derechos monopólicos de la gran industria farmacéutica, restringiendo la competencia y limitando el acceso a nuevos medicamentos genéricos. El Perú no ha sido ajeno a este proceso, suscribiendo un tratado de libre comercio con EEUU denominado Acuerdo de Promoción Comercial (APC) que involucró el capítulo de propiedadintelectual, así mismo, está negociando un segundo tratado comercial con la UE. En ambos casos las propuestaspresentadas han sido lesivas para el acceso a medicamentos, expresadas en cláusulas de Aspectos de PropiedadIntelectual Relacionados con el Comercio Plus (ADPIC Plus). Para algunos analistas, existe cierta complementariedad entre las pretensiones de EEUU y la UE, mientras que el primero consigue aumentar los estándares sustantivos comola protección de datos de prueba (conseguido en el APC), la UE conseguiría fortalecer la observancia asegurando la aplicación de las obligaciones contraídas. Esto resultaría en una escalada de la industria farmacéutica por ampliar losderechos de protección de la propiedad intelectual. El Estado Peruano debe asegurar el acceso a medicamentos através de políticas públicas que promuevan la competencia asegurando la introducción de genéricos al mercado. Para ello, es necesario prevenir nuevas obligaciones que atenten contra el acceso a éstos, no aceptando nuevos mecanismos de protección de los derechos de propiedad intelectual dentro de los tratados de libre comercio.

Through Free Trade Agreements, the economies of the United States of America (USA) and the European Union(EU) have been achieving a higher standard of protection of the intellectual property rights. This increases unduly the monopolist rights of the industry, restricting competition and limiting the access of new generic drugs. Peru has not been the exception to this process, subscribing a free trade agreement with the USA called Agreement of Commercial Promotion (APC) that involved the chapter of intellectual property, and in the same line, is now negotiating a second commercialagreement with the EU. In both cases, the presented proposals have been harmful for drug access, expressed in theclauses of the Aspects of Intellectual Property Related to the Commerce (ADPIC Plus). For some experts, there are certain complementarities between the goals of USA and those of the EU, while the first gets to increase the substantive standards such as the protection of testing data (achieved in the APC), the EU would strengthen the monitoring, thus ensuring the application of the obligations that have been acquired. This would result in a climbing of the pharmaceutical industry due to the widening of the intellectual property protection rights. The Peruvian State must guarantee the access to drugs through public policies that promote competition, ensuring the introduction of generics to the market. For this, it is necessary to prevent new obligations that attempt against access to these, by refusing new mechanisms of protectionof the intellectual property rights in the free trade agreements.
Descritores: Atos Internacionais
Comercialização de Medicamentos
Medicamentos Genéricos
Propriedade Intelectual de Produtos e Processos Farmacêuticos
-Peru
Responsável: PE1.1 - Oficina Universitária de Biblioteca


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Id: lil-564534
Autor: Brandi, Vikki; Stahl, Edmundo G.
Título: Equivalencia clínica entre el rociador nasal de propionato de fluticasona genérico y comercial en pacientes con rinitis alérgica / Clinical equival ence between generic and branded fluticasone propionate nasal spray in patients with allergic rhinitis
Fonte: Rev. peru. med. exp. salud publica;26(4):432-440, oct.-dic. 2009. tab, graf.
Idioma: es.
Resumo: Objetivo. Establecer la equivalencia clínica de un rociador nasal de propionato de fluticasona (RNF) genérico comparadocon dos formulas farmacéuticas comerciales del mismo producto (Flonase® y Flixonase®) durante la estación de polinización del cedro de montaña (Juniperus ashei) en Texas, EEUU. Materiales y métodos. Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, en grupos paralelos diseñado para investigar la seguridad y eficacia de RNF (200 mcg una vez al día), Flonase® (200 mcg una vez al día) y Flixonase® (200 mcg una vez al día), comparados con placebo, administrados por 13 a 15 días. Los pacientes registraron diariamente, en la mañana y en la tarde, sus síntomas nasales totales (SNT). La variable de desenlace primaria fue la suma de SNT en la mañana y tarde + 1. Las variables de desenlace secundarias fueron los SNT AM + 1 y SNT PM + 1, y la evaluación de seguridad. Resultados. No se observó diferencia estadísticamente significativa en ningún día de estudio, ni en todo el periodo de tratamiento, ni al punto de final entre SNT promedio tanto de Flonase® como Flixonase® y RNF. La equivalencia clínica entre RNF yFlonase® (cociente= 0,98; intervalo de confianza [IC] al 90 por ciento, 0,91 a 1,06), y entre RNF y Flixonase® (cociente= 1,02; IC 90 por ciento, 0,94 a 1,10) fue demostrada tanto para la variable de desenlace primaria como para las otras variables de eficacia. Conclusiones. Estos resultados respaldan la equivalencia clínica entre RNF 200 mcg una vez al día tanto con Flonase®como Flixonase® en el tratamiento de rinitis alérgica estacional.

Objective. The primary objective of this study was to establish the clinic equivalence of a new Fluticasone Propionate Aqueous Nasal Spray (FANS) compared to two commercially available active treatments of fluticasone propionate nasal spray (Flonase® and Flixonase®) during the mountain cedar (Juniperus ashei) pollen season in Texas. Material and methods. This was a multicenter, randomized, double-blind, double-dummy, active-controlled and placebo-controlled, parallel group study designed to investigate the safety and efficacy of FANS (200 mcg QD), Flonase® and Flixonase® (200 mcg QD) compared to placebo administered for 13 to 15 days. Patients recorded the total nasal symptoms dcores (TNSS) in a diary in the morning and evening every day. The primary endpoint was the patient-rated am and pm TNSS +1. Other key efficacy endpoints were patient-rated AM TNSS+1, patient-rated PM TNSS+1, and safety. Results. Mean TNSS values for Flonase® and Flixonase® were not statistically significantly different from FANS during any study day, over the entire treatment period, or at endpoint. Bioequivalence between FANS and Flonase® (ratio= 0.98, 90 per cent CI 0.91 to 1.06) as well as FANS and Flixonase® (ratio=1.02, 90 per cent CI 0.94 to 1.10) was demonstrated for the primary endpoint [Patient-Rated am and pm TNSS +1] as well as for the other key efficacy endpoints. Conclusions. The findings from this study support that FANS 200 mcg QD is therapeutically bioequivalent to both Flonase® and Flixonase® in the control ofthe symptoms of seasonal allergic rhinitis.
Descritores: Equivalência Terapêutica
Medicamentos Genéricos
Rinite Alérgica Sazonal
-Estudos Multicêntricos como Assunto
Limites: Humanos
Responsável: PE1.1 - Oficina Universitária de Biblioteca


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Id: lil-564533
Autor: Brandi, Vikki; Stahl, Edmundo G.
Título: Bioequivalencia de un rociador nasal de propionato de fluticasona genérico y el producto comercial / Bioequivalence of generic and branded fluticasone propionate nasal spray
Fonte: Rev. peru. med. exp. salud publica;26(4):426-431, oct.-dic. 2009. tab, graf.
Idioma: es.
Resumo: Objetivo. Comparar la bioequivalencia de tres formulas farmacéuticas nasales de propionato de fluticasona administradoscon un rociador nasal. Materiales y métodos. Ensayo clínico aleatorizado, abierto, de dosis única, cruzado a tresbrazos en 60 voluntarios sanos de ambos sexos entre 18 y 55 años de edad. El tratamiento consistió en una dosis nasalúnica (800 mcg) de rociador nasal de propionato de fluticasona (RNF), Flonase®, y Flixonase® en cinco visitas: una visita de selección, tres visitas de administración del medicamento y una de evaluación final. Se obtuvo muestras desangre a intervalos apropiados para análisis farmacocinético. El parámetro primario para determinar la bioequivalencia de las fórmulas farmacéuticas estudiadas fue el área bajo la curva de concentración-tiempo (AUC0-t). Como parámetro secundario se consideró la concentración máxima de la droga (Cmax). RNF se comparó separadamente a Flonase® y Flixonase®. Resultados. Se demostró bioequivalencia entre RNF y Flonase® (n=55) utilizando la transformación logarítmica invertida de AUC0-t (relación RNF a Flonase® = 1,021; IC90 por ciento, 0,88 a 1,19), y Cmax (relación = 0,995; IC90 por ciento, 0,92 a 1,07). Ambas medidas se encuentran dentro del rango aceptable de bioequivalencia (0,80 a 1,25). También se demostró la bioequivalencia entre RNF y Flixonase® (n=54) para AUC0-t (relación = 0,949; IC 90 por ciento 0,81 a 1,10) y Cmax (relación = 0,939, IC90 por ciento, 0,87 a 1,02). Se encontró que los tres tratamientos presentaron relativamente pocos efectos adversos. Conclusiones. RNF a una dosis de 800 mcg es bioequivalente tanto a Flonase® como Flixonase® administradas a voluntarios sanos. El perfil de seguridad de RNF es consistente con los de Flonase® y Flixonase®.

Objective: Comparison of the bioequivalence of three pharmaceutical formulations of fluticasone propionate nasal administered with a nasal spray (FANS). Materials y Methods: A randomized, open-label, single-dose, three-way crossover study in 60 healthy volunteers of both sexes between 18 and 55 years old. Subjects received a single intranasal dose (800 mcg) of FANS, Flonase®, and Flixonase® in 5 visits: screening, 3 dosing visits, and end of study. Forty-eight hours to 7 days were allowed between dosing visits. Blood was drawn for pharmacokinetics analysis at appropriate intervals. The primary pharmacokinetic parameter for determination of bioequivalence of the formulations was the areaunder the plasma concentration-time curve (AUC0-t). Secondary parameters included the maximum plasma concentration (Cmax). FANS was compared to Flonase® and to Flixonase® separately. Results: Bioequivalence between FANS and Flonase® (n=55) was demonstrated by the inverse log transformed AUC0-t (ratio FANS to Flonase® = 1.021; 90 per cent CI, 0.88 to 1.19), and Cmax, (ratio = 0.995; 90 per cent CI, 0.92 to 1.07), which are within the acceptable range of 0.80 to 1.25. Bioequivalence between FANS and Flixonase® (n=54) was also demonstrated for AUC0-t (ratio = 0.949; 90 per cent CI 0.81 to 1.10) and Cmax (ratio = 0.939, 90 per cent CI, 0.87 to 1.02). Active treatments were well tolerated and there were relatively few adverse events. Conclusions: A single dose of FANS 800 mcg is pharmacokinetically bioequivalent to both Flonase® and Flixonase® when administered to healthy subjects. The safety profile of FANS was consistent with that noted for Flonase® and Flixonase®.
Descritores: Equivalência Terapêutica
Farmacocinética
Medicamentos Genéricos
Rinite Alérgica Perene
Limites: Humanos
Masculino
Feminino
Adulto
Pessoa de Meia-Idade
Tipo de Publ: Ensaio Clínico
Responsável: PE1.1 - Oficina Universitária de Biblioteca


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Id: lil-559306
Autor: Villalva Rojas, Ofelia; Grande Ortiz, Miguel; Ortiz, Juan; Isasi, Jacqueline; Yantas, Dula; Fiestas, Víctor.
Título: Estudio de bioequivalencia del ibuprofeno 400 mg tabletas / Bioquivalence study of ibuprofen 400 mg tablets
Fonte: Rev. peru. med. exp. salud publica;24(4):356-362, oct.-dic. 2007. tab, graf.
Idioma: es.
Resumo: Objetivo. Determinar la biodisponibilidad de dos formulaciones de ibuprofeno 400mg tabletas, para establecer si el medicamento multifuente (genérico) es bioequivalente al de referencia (Motrin® 400mg). Materiales y métodos. Se diseñó un estudio abierto, randomizado, cruzado, dos periodos, con siete días de lavado, con 12 voluntarios sanos de ambos sexos, entre 21 y 48 años, quienes ingirieron una tableta del medicamento genérico o de referencia, según randomización, con 200mL de agua. Luego de ingerir el medicamento se colectó 4mL de sangre por voluntario para la cuantificación plasmática de ibuprofeno. Las muestras de plasma se analizaron por cromatografía líquida acoplada al espectrofotómetro de masas (LC-MS/MS) con ionización electrospray ión negativo, aplicando monitoreo de reacción selectiva. La bioequivalencia se determinó con los parámetros farmacocinéticos de área bajo la curva AUC(0-t), UC(0-∞) y concentración máxima (Cmax). Resultados. Según análisis estadístico, se encontraron: AUC multifuente(0-t) = 86,85 (μg*h)/mL, AUCRef.(0-t)= 81,20 (μg*h)/mL, AUCmultifuente(0-∞)= 88,67 (μg*h)/mL, AUCRef.(0-∞)= 82,83(μg*h)/mL, Cmáxmultifuente = 17,70 ug/mL, CmáxRef. =18,09 μg/mL, con rango de 0,93-1,24 para AUC(0-t), 0,93-1,24 para AUC(0-∞) y 0,81-1,19 para Cmax. Conclusión. Los valores encontrados de ibuprofeno están dentro de los requisitos de la OMS y la FDA, para establecer bioequivalencia (0,80û1,25), demostrándose que el ibuprofeno genérico es bioequivalente al de referencia en velocidad y cantidad de ibuprofeno absorbido en el organismo.

Objective. To determine the bioavailability of two dosage forms of ibuprofen 400mg tablets, for establishing if the multisource (generic) drug is bioequivalent to the reference (Motrin® 400mg tablets). Materials and methods. It was designed an opened study, randomized, two periods, cross over, and seven days washout period, with 12 healthy volunteers (male and female), between 21 and 48 years old, who have taken one tablet of the multisource or reference tablets; according to randomization; with 200 mL of water. After drug intake 4 mL of blood was collected from each volunteer, for quantification of ibuprofen. The plasma samples with ibuprofen and sodium diclofenac (internal standard) were analyzed by liquid chromatography tandem mass spectrometry (LC-MS/MS) with negative ion electrospray ionization using selected reaction monitoring. The bioequivalence was established with pharmacokinetics parameters: area under the curve AUC(0-t), AUC(0-∞) and maximum concentration (Cmax). Results. According to statistical analysis were founded: AUCmultisource(0-t) = 86.85 (ug*h)/mL, AUCRef.(0-t) = 81.20 (ug*h)/mL, AUCmultisource(0-∞) = 88.67 (ug*h)/mL, AUCRef.(0-∞) = 82.83 (ug*h)/mL, Cmáxmultisource = 17.70 ug/mL, CmáxRef.=18.09 ug/mL, with intervals of 0.93-1.24 for AUC(0-t), 0.93-1.24 for AUC(0-∞) and 0.81-1.19 for Cmax. Conclusions. The values founded for AUC(0-t), AUC(0-∞) and Cmax are within the established limits by WHO and FDA (0,80 -1,25), so ibuprofen 400mg tables; multisource drug, is bioequivalent to Motrin 400mg tablets, with regard to both the rate and extent of absorption.
Descritores: Anti-Inflamatórios não Esteroides
Disponibilidade Biológica
Equivalência Terapêutica
Farmacocinética
Ibuprofeno
Medicamentos Bioequivalentes
Medicamentos Genéricos
Limites: Humanos
Masculino
Feminino
Adulto
Pessoa de Meia-Idade
Responsável: PE1.1 - Oficina Universitária de Biblioteca



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