Análisis bibliográfico de biodisponibilidad y bioequivalencia en Ecuador y Región Andina
Fecha
2021
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
La presente investigación analizó los contenidos de las normativas, resoluciones, guías o instructivos de biodisponibilidad y bioequivalencia de los países de la región andina (Venezuela, Colombia, Ecuador, Perú y Bolivia), todos ellos estados miembros de la OPS/OMS, con la finalidad de conocer el soporte legal y los avances de los criterios y requisitos de los medicamentos que requieran la presentación de estudios de BD y BE ya sea para solicitar el registro sanitario o la intercambiabilidad de los medicamentos. La investigación es bibliográfica documental y se la realizó mediante de una metodología de tipo no experimental con un diseño analítico descriptivo retrospectivo.
Se evidenció que la resolución emitida por el ARCSA del 2018 es una adaptación de la resolución 1124 del 2016 emitida por el INVIMA de Colombia, en el cual se establece los criterios y requisitos para el estudio de BD y BE de medicamentos. Todos los países disponen de sólidas bases legales, documentación como guías, listados y formatos que permiten a sus respectivas agencias mantener un control indudable y oportuno en el cumplimiento de la BE para el registro sanitario. En el caso de Bolivia (AGEMED) no se dispone de información oficial.
Finalmente, el Ecuador es el único país que, a pesar de tener la legislación, no cuenta con un Centro de Investigación certificado, ya sea nacional o privados, ni tampoco dispone de las Unidades Especiales Contratadas que pueden ser certificadas por separado y así cumplir con los estudios de BD y BE.
This research analyzed the contents of the regulations, resolutions, guides or instructions on bioavailability and bioequivalence of the countries of the Andean region (Venezuela, Colombia, Ecuador, Peru and Bolivia), all of them member states of PAHO. / WHO, in order to know the legal support and the advances of the criteria and requirements of the drugs that require the presentation of BD and BE studies either to request the sanitary registration or the interchangeability of the drugs. The research is documentary bibliographic and its was by means of a non- experimental methodology with a retrospective descriptive analytical design. It was evidenced that the resolution issued by the ARCSA of 2018 is an adaptation of resolution 1124 of 2016 issued by the INVIMA of Colombia, which establishes the criteria and requirements for the study of BD and BE of drugs. All countries have solid legal bases, documentation such as guides, lists and formats that allow their respective agencies to maintain undoubted and timely control in compliance with the BE for the sanitary registry. In the case of Bolivia (AGEMED) there is no official information available. Finally, Ecuador is the only country that, despite having the legislation, does not have a certified BD and BE Research Center, either national or private, nor does it have Special Contracted Units that can be certified separately and so comply with the BD and BE studies.
This research analyzed the contents of the regulations, resolutions, guides or instructions on bioavailability and bioequivalence of the countries of the Andean region (Venezuela, Colombia, Ecuador, Peru and Bolivia), all of them member states of PAHO. / WHO, in order to know the legal support and the advances of the criteria and requirements of the drugs that require the presentation of BD and BE studies either to request the sanitary registration or the interchangeability of the drugs. The research is documentary bibliographic and its was by means of a non- experimental methodology with a retrospective descriptive analytical design. It was evidenced that the resolution issued by the ARCSA of 2018 is an adaptation of resolution 1124 of 2016 issued by the INVIMA of Colombia, which establishes the criteria and requirements for the study of BD and BE of drugs. All countries have solid legal bases, documentation such as guides, lists and formats that allow their respective agencies to maintain undoubted and timely control in compliance with the BE for the sanitary registry. In the case of Bolivia (AGEMED) there is no official information available. Finally, Ecuador is the only country that, despite having the legislation, does not have a certified BD and BE Research Center, either national or private, nor does it have Special Contracted Units that can be certified separately and so comply with the BD and BE studies.
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BIOEQUIVALENCIA, INTERCAMBIABILIDAD, LEGISLACIÓN DE MEDICAMENTOS