Estudos de medicamentos biosimilares

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acronym in Portuguese) is fully satisfied with the evidence of their quality, efficacy and safety, presented by a pharmaceutical industry that strive for this registration. With the patent expiration, pharmaceutical companies are attracted to produce biological medicines called biosimilar or biogenerics or simply generics, whose approval may result in reduced treatment costs. But it is necessary that the biosimilar be, at least, equally efective and safe and without contaminants in relation to the original. Recent consensus guidelines aim to establish criteria for efcacy and safety of these medicines. Preclinical studies in vitro and in vivo, the origin of raw materials and clinical studies phase I, II and III are recommended for biosimilar medicine registration in the international market. Low molecular weight heparins are found in this situation. In this review we specifcally addressed this type of medicine, which could serve as a benchmark for other biosimilar medicines.

Normas de origen y procedimientos para su administración en América Latina

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Regulación y competencia en el mercado de medicamentos: experiencias relevantes para América Latina

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El comercio internacional de servicios de salud en México: fortalezas, oportunidades, debilidades y amenazas

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Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula

With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.

La gestión local, su administración, desafíos y opciones para el fortalecimiento productivo municipal en Caranavi, Departamento de La Paz, Bolivia

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Administración del agua en América Latina: situación actual y perspectivas

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Sistema de administración del agua en Chile

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Planificación y administración hídrica en el Perú

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Planificación y administración hídrica en Centroamérica

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Integrando economía, legislación y administración en la gestión del agua y sus servicios en América Latina y el Caribe

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Administración del agua en América Latina y el Caribe en el umbral del siglo XXI

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Banco de éxitos de la administración pública colombiana

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La tributación en América Latina: tendencias estructurales e impacto en la administración

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