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Interchangeability among therapeutics equivalents of lamotrigine in the treatment of refractory epilepsy patients: risks and benefits

GIROLINETO, Beatriz M. P.; ALEXANDRE JR., Veriano; QUEIROZ, Regina H. C.; FELETTI, Fausto; SAKAMOTO, Americo C.; PEREIRA, Leonardo R. L.
Fonte: REVISTA DE NEUROLOGIA Publicador: REVISTA DE NEUROLOGIA
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
37.35%
Introduction. Epilepsy is a condition characterized by signs and symptoms of neurological disorder. Lamotrigine has been widely used, mainly due to their greater tolerability and lower rate of drug interactions with other antiepileptic drugs however the newest antiepileptic drugs have high cost to patient. In Brazil there are three different sort of pharmaceutical equivalents (reference, generic and similar), and the Brazilian health care authorities offers to users the possibility to receive them free of charge. Moreover these pharmaceutical equivalents can change during the treatment of epilepsy because this authorities buy the cheapest by public tender two or three times a year. Aim. To evaluate the clinical and laboratory findings related to the most frequently used therapeutic equivalents of lamotrigine (reference drugs and similar products). Patients and methods. Two similar formulations (A and B) and one reference (C) were tested in nine epileptic refractory patients. The study was divided into three periods of 42 days, one for each formulation, and medical data about the frequency of seizures, the occurrence of side effects and measurement of plasma concentrations of lamotrigine were collected. Results. The average number of seizures/week and plasma concentration of lamotrigine for formulations A...

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Pereira Girolineto, Beatriz Maria; Alexandre Junior, Veriano; Sakamoto, Americo Ceiki; Leira Pereira, Leonardo Regis
Fonte: UNIV SAO PAULO, CONJUNTO QUIMICAS; SAO PAULO Publicador: UNIV SAO PAULO, CONJUNTO QUIMICAS; SAO PAULO
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
37.53%
Epilepsy is the most common serious neurological disorder worldwide. Approximately 70% of patients with epilepsy have their seizures controlled by clinical and pharmacological treatment. This research evaluated the possible influence of interchangeability among therapeutic equivalents of LTG on the clinical condition and quality of life of refractory epileptic patients. The study was divided into three periods of 42 days, and an equivalent therapeutic LTG randomly dispensed for each period (two similars - formulations A and B, and the reference product - formulation C). The mean dose of LTG was 5.5 mg/kg/day. The presence of side effects tends to have a greater deleterious effect on quality of life of refractory epileptics compared to variations in number of seizures or changes in plasma concentrations. The results showed that independently of the drug prescribed, interchangeability among therapeutic equivalents can negatively impact epilepsy control.

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Girolineto, Beatriz Maria Pereira; Alexandre Junior, Veriano; Sakamoto, Américo Ceiki; Pereira, Leonardo Régis Leira
Fonte: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
27.35%
Epilepsy is the most common serious neurological disorder worldwide. Approximately 70% of patients with epilepsy have their seizures controlled by clinical and pharmacological treatment. This research evaluated the possible influence of interchangeability among therapeutic equivalents of LTG on the clinical condition and quality of life of refractory epileptic patients. The study was divided into three periods of 42 days, and an equivalent therapeutic LTG randomly dispensed for each period (two similars - formulations A and B, and the reference product - formulation C). The mean dose of LTG was 5.5 mg/kg/day. The presence of side effects tends to have a greater deleterious effect on quality of life of refractory epileptics compared to variations in number of seizures or changes in plasma concentrations. The results showed that independently of the drug prescribed, interchangeability among therapeutic equivalents can negatively impact epilepsy control.

IEC-61850: interoperabilidade e intercambialidade entre equipamentos de supervisão, controle e proteção através das redes de comunicação de dados; IEC-61850: interoperability and interchangeability between supervision, control and protection equipment using data communication networks

Miranda, Juliano Coêlho
Fonte: Biblioteca Digitais de Teses e Dissertações da USP Publicador: Biblioteca Digitais de Teses e Dissertações da USP
Tipo: Dissertação de Mestrado Formato: application/pdf
Publicado em 27/04/2009 Português
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37.53%
Os sistemas de comunicação de dados sempre foram considerados um fator crítico na operação em tempo real do sistema elétrico de potência, devido a necessidade de decisões rápidas e precisas em pontos geograficamente distribuídos, desde usinas geradoras de energia até interfaces de usuários. Com a tecnologia digital, as medições, sinalizações e comandos são encapsulados em pacotes de dados que trafegam na rede da subestação, utilizando protocolos que estabelecem os formatos, as regras, os métodos, negociando e concordando no uso de parâmetros, que assegurem o transporte de informações entre dois ou mais dispositivos do sistema de automação da subestação. Uma vez que o número de protocolos de comunicação tem se tornado um desafio para usuários e fabricantes, criando ilhas de informação, o padrão IEC-61850 busca harmonizar a diversidade de equipamentos e fabricantes, e possibilitar a integração de dados para que o máximo dos benefícios possa ser extraído. Como proposta que principia esta dissertação, ambiciona-se expor a implementação no Laboratório de Sistemas de Energia Elétrica, da Universidade de São Paulo, de uma infra-estrutura de comunicação de dados e redes de computadores, Intranet...

Emprego de meta-análise para avaliação da intercambialidade entre medicamentos; Use of meta-analysis in order to evaluate the interchangeable of medicines

Schramm, Simone Grigoleto
Fonte: Biblioteca Digitais de Teses e Dissertações da USP Publicador: Biblioteca Digitais de Teses e Dissertações da USP
Tipo: Tese de Doutorado Formato: application/pdf
Publicado em 16/12/2008 Português
Relevância na Pesquisa
17.65%
No Brasil, os medicamentos genéricos e similares devem ser submetidos a ensaios de biodisponibilidade relativa/ bioequivalência para comprovação de sua intercambiabilidade com o medicamento referência. Nestes ensaios, o medicamento genérico, ou similar, é comparado com o medicamento referência em um estudo cruzado, mas não é comparado com outros genéricos ou similares do mercado. Desta forma, podemos afirmar que todo medicamento genérico ou similar é intercambiável com o medicamento de referência, mas não temos informações sobre a intercambiabilidade de um genérico com outro genérico ou com um similar. Entretanto, é comum que os pacientes substituam não apenas medicamento de referência pelo genérico ou similar correspondente, mas também um genérico por outro genérico, ou um genérico por um similar. Assim sendo, a questão que se coloca é se essas substituições entre genéricos e entre genérico e similar, podem gerar problemas de eficácia e/ou segurança para os pacientes. Para tentar responder essa questão foi proposta uma análise estatística, a meta-análise, onde seria possível avaliar a biodisponibilidade relativa/ bioequivalência entre genéricos, entre similares ou genérico e similar a partir dos resultados dos ensaios em que estes medicamentos foram comparados ao referência. Assim...

Utilização de syngas em substituição a combustíveis gasoso em processos siderúrgicos

Caputo, Paula Diniz
Fonte: Universidade Estadual Paulista (UNESP) Publicador: Universidade Estadual Paulista (UNESP)
Tipo: Dissertação de Mestrado Formato: 72 f. : il.
Português
Relevância na Pesquisa
27.06%
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES); Pós-graduação em Engenharia Mecânica - FEG; Esta dissertação analisa a possibilidade de utilizar combustíveis gasosos alternativos para reduzir o consumo de gás de coqueria em usinas siderúrgicas integradas. Foram consideradas misturas a) de gás de coqueria com gases de gaseificação e b) de gás natural com gases de gaseificação, para substituir o gás de coqueria puro e misturas do gás de coqueria com gás de alto forno. Os dois parâmetros principais que definem a intercambiabilidade entre os gases foram o Índice de Wobbe e o Índice de Weaver relativo a descolamento de chama. O percentual de economia de gás de coqueria foi calculado para as diversas misturas consideradas.; This dissertation analyzes the possibility of using alternate fuel gases to reduce the consumption of coke oven gas in integrated steel making plants. The following gas mixtures were considered: a) coke oven gas with different gasification gases and b) natural gas with different gasification gases to substitute either pure coke oven gas or mixtures of coke oven gas with blast furnace gas. Eight gasification gases from biomass and coal were selected from the literature as prospective substitutes. The two main parameters that defined the interchangeability were the Wobbe Index and the Weaver Index related to flame blow out. The economy of coke oven gas was calculated for all considered alternate gases.

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Girolineto,Beatriz Maria Pereira; Junior,Veriano Alexandre; Sakamoto,Américo Ceiki; Pereira,Leonardo Régis Leira
Fonte: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/03/2012 Português
Relevância na Pesquisa
37.53%
Epilepsy is the most common serious neurological disorder worldwide. Approximately 70% of patients with epilepsy have their seizures controlled by clinical and pharmacological treatment. This research evaluated the possible influence of interchangeability among therapeutic equivalents of LTG on the clinical condition and quality of life of refractory epileptic patients. The study was divided into three periods of 42 days, and an equivalent therapeutic LTG randomly dispensed for each period (two similars - formulations A and B, and the reference product - formulation C). The mean dose of LTG was 5.5 mg/kg/day. The presence of side effects tends to have a greater deleterious effect on quality of life of refractory epileptics compared to variations in number of seizures or changes in plasma concentrations. The results showed that independently of the drug prescribed, interchangeability among therapeutic equivalents can negatively impact epilepsy control.

The Intergradation, Genetic Interchangeability and Interpretation of Gene Conversion Spectrum Types

Lamb, Bernard C.; Ghikas, Aglaia
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /05/1979 Português
Relevância na Pesquisa
27.06%
In the Pasadena strains of Ascobolus immersus, the gene conversion propperties of 29 induced (nine UV, nine NG, and 11 ICR-170) and nine spontaneous white-ascospore mutations have been studied. Each mutant was crossed to three types of derived wild-type strains; single mutants often gave very different conversion results in the three types of crosses, with any or all of the following changes in: percentage with post-meiotic segregation among aberrant-ratio asci; percentage with conversion to wild type among aberrant-ratio asci; and in total conversion frequency. — These results are compared with those of Leblon (1972 a, b) from Ascobolus immersus and Yu-Sun, Wickramaratne and Whitehouse (1977) from Sordaria brevicollis. It is shown that conversion spectrum types are not necessarily distinct, but can completely intergrade, on the criteria of both post-meiotic segregation frequency and direction of correction. Genetic differences between strains in the present work resulted in much interchangeability of spectrum types for the same mutation in different crosses; e.g., from type C in one cross to type B/D type in another cross, although the mutation is presumably of the same molecular type (addition or deletion frame shift, or base substitution) in each cross. These changes of conversion properties for a given mutation in different crosses mean that previous interpretations of spectrum types in terms of specific conversion properties for various molecular types of mutation are inapplicable...

Interchangeability of Two 500 Mg Amoxicillin Capsules with One 1000 Mg Amoxicillin Tablet After a Single Oral Administration

Zaid, A. N.; Cortesi, R.; Kort, J.; Sweileh, W.
Fonte: Medknow Publications Publicador: Medknow Publications
Tipo: Artigo de Revista Científica
Publicado em //2010 Português
Relevância na Pesquisa
27.06%
The aim of the study was to evaluate if two capsules (Amoxil® capsules, 500 mg/capsule) and one tablet (Amoxicare® tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters. For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers, divided into two groups of 12 subjects each. One group was treated with the reference standard (Amoxil®) and the other one with the generic tablet Amoxicare®, with a crossover after a wash-out period of 7 days. Blood samples were collected at fixed time intervals and amoxicillin was determined by a validated HPLC method. The pharmacokinetic parameters AUC0-8, AUC0-∞, Cmax, Tmax, Ke and T1/2 were determined for both formulations and statistically compared to evaluate the bioequivalence between the two brands of amoxicillin, using the statistical model recommended by the FDA. Cmax and AUC0-∞ were statistically analyzed using analysis of variance (ANOVA); no statistically significant difference was observed between the two formulations. The 90% confidence intervals between the mean values of Cmax and AUC0-∞ fall within the FDA specified bioequivalent limits (80-125%) suggesting that the two products are bioequivalent and the two formulations are interchangeable. Based on these findings it was concluded that the practice of interchangeability between the above formulations to achieve better patient compliance could be followed without compromising the extent of amoxicillin absorption.

Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report

Chen, Mei-Ling; Shah, Vinod P.; Crommelin, Daan J.; Shargel, Leon; Bashaw, Dennis; Bhatti, Masood; Blume, Henning; Dressman, Jennifer; Ducharme, Murray; Fackler, Paul; Hyslop, Terry; Lutter, Lorelei; Morais, Jose; Ormsby, Eric; Thomas, Saji; Tsang, Yu Chu
Fonte: Springer US Publicador: Springer US
Tipo: Artigo de Revista Científica
Publicado em 16/08/2011 Português
Relevância na Pesquisa
27.06%
Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.

Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation

Johnston, Atholl
Fonte: BMJ Publishing Group Publicador: BMJ Publishing Group
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
27.06%
The calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are the mainstay of immunosuppression in solid organ transplantation. Generic formulations of these drugs are now available. With increasing pressure on healthcare budgets and the consequent need to match health expectations to available resources, substitution with a generic product appears an attractive option to reduce costs. Approval of generic products differs from innovator drugs, and narrow therapeutic index drugs (NTIs; including CNIs) bring their own particular considerations. With NTIs, small variations in drug exposure could result in reduced immunosuppression or drug toxicity with potentially adverse effects on patient outcomes. NTIs are subject to stricter regulatory approval versus many other generic drugs. However, different generic formulations may still not necessarily be therapeutically equivalent in individuals, raising the possibility of significant differences in exposure between products. Although regional recommendations vary, many guidelines emphasise the need for NTI drug substitution to be initiated by the transplant physician, thus ensuring careful therapeutic monitoring and reduced negative patient impact. The need for therapeutic monitoring during generic substitution has important implications for the overall costs of generic treatment as these costs have to be factored in to the potential savings made from using generic formulations. The reduced acquisition costs of generic products may not necessarily translate into lower overall healthcare costs. This article examines the issue of equivalence and interchangeability of NTI drugs used in organ transplantation...

Assessing Interchangeability at Cluster-Levels with Multiple-Informant Data: (Interchangeability of Multiple-Informant Data)

Luo, Zhehui; Breslau, Joshua; Gardiner, Joseph C.; Chen, Qiaoling; Breslau, Naomi
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
27.35%
Studies examining the relationship between neighborhood social disorder and health often rely on multiple informants. Such studies assume interchangeability of the latent constructs derived from multiple-informant data. Existing methods examining this assumption do not clearly delineate the uncertainty at individual levels from that at neighborhood levels. We propose a multi-level variance component factor model that allows this delineation. Data come from a survey of a representative sample of children born between 1983 and 1985 in the inner city of Detroit and nearby middle-class suburbs. Results indicate that the informant-level models tend to exaggerate the effect of places due to differences between persons. Our evaluations of different methodologies lead to the recommendation of the multi-level variance component factor model whenever multiple-informant reports can be aggregated at a neighborhood level.

Statistical and regulatory considerations in assessments of interchangeability of biological drug products

Tóthfalusi, Lászlo; Endrényi, László; Chow, Shein-Chung
Fonte: Springer Berlin Heidelberg Publicador: Springer Berlin Heidelberg
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
27.86%
When the patent of a brand-name, marketed drug expires, new, generic products are usually offered. Small-molecule generic and originator drug products are expected to be chemically identical. Their pharmaceutical similarity can be typically assessed by simple regulatory criteria such as the expectation that the 90 % confidence interval for the ratio of geometric means of some pharmacokinetic parameters be between 0.80 and 1.25. When such criteria are satisfied, the drug products are generally considered to exhibit therapeutic equivalence. They are then usually interchanged freely within individual patients. Biological drugs are complex proteins, for instance, because of their large size, intricate structure, sensitivity to environmental conditions, difficult manufacturing procedures, and the possibility of immunogenicity. Generic and brand-name biologic products can be expected to show only similarity but not identity in their various features and clinical effects. Consequently, the determination of biosimilarity is also a complicated process which involves assessment of the totality of the evidence for the close similarity of the two products. Moreover, even when biosimilarity has been established, it may not be assumed that the two biosimilar products can be automatically substituted by pharmacists. This generally requires additional...

Metanálise de estudos de bioequivalência : a intercambiabilidade de genéricos e similares que contêm Hidroclorotiazida é possível, mas não àqueles com Maleato de Enalapril; Meta-analysis for bioequivalence studies : interchangeability of generic drugs and similar containing Hydrochlorothiazide is possible but not with Enalapril Maleate

Lopes, Renato Almeida; Neves, Francisco de Assis Rocha
Fonte: Sociedade Brasileira de Nefrologia Publicador: Sociedade Brasileira de Nefrologia
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
27.65%
INTRODUÇÃO: O programa de genéricos no Brasil propiciou maior acesso da população a medicamentos. Para garantir a intercambiabilidade entre medicamentos referência e genérico ou similar, é necessário que eles sejam bioequivalentes. Com o crescimento do número de medicamentos genéricos, é comum que pacientes o substituam por outro genérico ou similar. Contudo, essa troca pode não garantir a manutenção da bioequivalência. Para avaliar a segurança na intercambiabilidade entre diferentes genéricos e similares com Hidroclorotiazida e Maleato de Enalapril, foi realizada metanálise de vários estudos de bioequivalência que utilizaram esses medicamentos. MÉTODOS: Foram utilizados dados provenientes de estudos de bioequivalência de genéricos e similares registrados pela Agência Nacional de Vigilância Sanitária (Anvisa). A compatibilidade dos dados de cada um dos estudos foi analisada, e a determinação de um intervalo de confiança para as diferenças entre as médias dos parâmetros farmacocinéticos, área sob a curva (ASC) e concentração plasmática máxima (Cmáx ), foi feita para cada estudo por meio da metanálise. RESULTADOS: A intercambiabilidade entre as combinações dos três produtos com Hidroclorotiazida foi confirmada com base nos intervalos de confiança obtidos. Para os medicamentos com Maleato de Enalapril...

RXPERT: A Decision Support Expert System for Drug Product Interchangeability Assessment

Greer, Marianne L.; Quinn, Trevor J.; Greer, Jim E.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em 08/11/1989 Português
Relevância na Pesquisa
27.06%
A knowledge-based expert system has been developed to support human decision makers who assess drug products for inclusion in the Saskatchewan Formulary. Formulary inclusion and deletion decisions are made by two committees. The Drug Quality Assessment Committee (DQAC) performs the initial clinical evaluation and makes recommendations to the Formulary Committee (FC). The FC then considers the practical and administrative implications of the DQAC recommendations and makes recommendations to the Minister of Health. The RXPERT Formulary Advisor is designed to model and support the decision processes of the two committees, primarily in the area of interchangeability among chemically equivalent products. Committee meeting minutes were analyzed and members observed and interviewed to suggest rules which form the basis of the RXPERT advisor. The prototype expert system attempts to model committee decision making, based on multiple experts with overlapping, but distinctly focussed, areas of expertise. The major anticipated contribution is screening of routine decisions to ensure efficient and consistent assessment and free experts' time for more complex cases.

Interchangeability of Electrocardiography and Blood Pressure Measurement for Determining Heart Rate and Heart Rate Variability in Free-Moving Domestic Pigs in Various Behavioral Contexts

Krause, Annika; Tuchscherer, Armin; Puppe, Birger; Langbein, Jan
Fonte: Frontiers Media S.A. Publicador: Frontiers Media S.A.
Tipo: Artigo de Revista Científica
Publicado em 02/11/2015 Português
Relevância na Pesquisa
27.06%
This study assessed the interchangeability between heart rate (HR) and heart rate variability (HRV) measures derived from a series of interbeat intervals (IBIs) recorded via electrocardiogram (ECG) and intra-arterial blood pressure (BP) in various behavioral contexts. Five minutes of simultaneously recorded IBIs from ECG and BP signals in 11 female domestic pigs during resting, feeding, and active behavior were analyzed. Comparisons were made for measures of HR, the standard deviation of IBIs, and the root mean of the squared distances of subsequent IBIs derived from ECG and BP signals for each behavior category using statistical procedures with different explanatory power [linear regression, intraclass correlation coefficient (ICC), Bland and Altman plots, and analysis of variance (ANOVA)]. Linear regression showed a strong relationship for HR during all behaviors and for HRV during resting. Excellent ICCs [lower 95% confidence intervals (CI) >0.75] and narrow limits of agreement in all behavior categories were found for HR. ICCs for HRV reached the critical lower 95% CI value of 0.75 only during resting. Using Bland and Altman plots, HRV agreement was unacceptable for all of the behavior categories. ANOVA showed significant differences between the methods in terms of HRV. BP systematically overestimated HRV compared with ECG. Our findings reveal that HR data recorded via BP agree well those recorded using ECG independently of the activity of the subject...

Equilibria Interchangeability in Cellular Games

Naumov, Pavel; Protzman, Margaret
Fonte: Universidade Cornell Publicador: Universidade Cornell
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
27.53%
The notion of interchangeability has been introduced by John Nash in one of his original papers on equilibria. This paper studies properties of Nash equilibria interchangeability in cellular games that model behavior of infinite chain of homogeneous economic agents. The paper shows that there are games in which strategy of any given player is interchangeable with strategies of players in an arbitrary large neighborhood of the given player, but is not interchangeable with the strategy of a remote player outside of the neighborhood. The main technical result is a sound and complete logical system describing universal properties of interchangeability common to all cellular games.

A Partial Taxonomy of Substitutability and Interchangeability

Karakashian, Shant; Woodward, Robert; Choueiry, Berthe Y.; Prestwhich, Steven; Freuder, Eugene C.
Fonte: Universidade Cornell Publicador: Universidade Cornell
Tipo: Artigo de Revista Científica
Publicado em 22/10/2010 Português
Relevância na Pesquisa
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Substitutability, interchangeability and related concepts in Constraint Programming were introduced approximately twenty years ago and have given rise to considerable subsequent research. We survey this work, classify, and relate the different concepts, and indicate directions for future work, in particular with respect to making connections with research into symmetry breaking. This paper is a condensed version of a larger work in progress.; Comment: 18 pages, The 10th International Workshop on Symmetry in Constraint Satisfaction Problems (SymCon'10)

Interchangeability among therapeutic equivalents of lamotrigine: evaluation of quality of life

Girolineto, Beatriz Maria Pereira; Junior, Veriano Alexandre; Sakamoto, Américo Ceiki; Pereira, Leonardo Régis Leira
Fonte: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
Tipo: info:eu-repo/semantics/article; info:eu-repo/semantics/publishedVersion; ; ; ; ; ; Formato: application/pdf
Publicado em 01/03/2012 Português
Relevância na Pesquisa
27.35%
Epilepsy is the most common serious neurological disorder worldwide. Approximately 70% of patients with epilepsy have their seizures controlled by clinical and pharmacological treatment. This research evaluated the possible influence of interchangeability among therapeutic equivalents of LTG on the clinical condition and quality of life of refractory epileptic patients. The study was divided into three periods of 42 days, and an equivalent therapeutic LTG randomly dispensed for each period (two similars - formulations A and B, and the reference product - formulation C). The mean dose of LTG was 5.5 mg/kg/day. The presence of side effects tends to have a greater deleterious effect on quality of life of refractory epileptics compared to variations in number of seizures or changes in plasma concentrations. The results showed that independently of the drug prescribed, interchangeability among therapeutic equivalents can negatively impact epilepsy control.; Epilepsia é o distúrbio neurológico grave mais comum no mundo todo. Aproximadamente 70% dos pacientes com epilepsia têm suas crises controladas com tratamento clínico e farmacológico. Esta pesquisa avaliou a possível interferência da intercambialidade entre equivalentes terapêuticos da lamotrigina na condição clínica e na qualidade de vida dos pacientes com epilepsia refratária. O estudo foi dividido em três períodos de 42 dias e em cada período foi dispensado um equivalente terapêutico...

Comparison of two recombinant hepatitis B vaccines and their interchangeability in Argentine infants

Tregnaghi,Miguel; Ussher,José; Baudagna,Ana María; Calvari,Miriam; Graña,Gabriela
Fonte: Organización Panamericana de la Salud Publicador: Organización Panamericana de la Salud
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/01/2004 Português
Relevância na Pesquisa
27.06%
OBJECTIVE: To compare two pediatric recombinant hepatitis B vaccines-the Engerix-B reference vaccine and the Euvax-B vaccine-in terms of immunogenicity and reactogenicity, and also to investigate their interchangeability, that is, whether a three-dose hepatitis B vaccination schedule begun with a first dose of Engerix-B could be completed with two doses of Euvax-B. METHODS: This study was conducted in the city of Córdoba, Argentina, from March 1999 through February 2000. Three groups of Argentine newborns (100 per group) were vaccinated at 0, 1, and 6 months of age with hepatitis B vaccine: group A, three doses of Euvax-B; group B, three doses of Engerix-B; and group C, one dose of Engerix-B followed by two doses of Euvax-B. Reactogenicity was evaluated based on parental reporting of any solicited local or systemic event occurring during the 7-day period following vaccination. Whether Euvax-B and Engerix-B were clinically identical was assessed in terms of the seroprotection rates (antibodies to hepatitis B surface antigen (anti-HBsAg) >10 milli-international units per mL (mIU/mL) 2 months after the third vaccination). RESULTS: Reactogenicity was low in all three groups. Five months after the second dose (that is, immediately prior to the third vaccination)...