<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2340-9894</journal-id>
<journal-title><![CDATA[Ars Pharmaceutica (Internet)]]></journal-title>
<abbrev-journal-title><![CDATA[Ars Pharm]]></abbrev-journal-title>
<issn>2340-9894</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Granada]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2340-98942021000300315</article-id>
<article-id pub-id-type="doi">10.30827/ars.v62i3.15917</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Calidad biofarmacéutica e intercambiabilidad de medicamentos]]></article-title>
<article-title xml:lang="en"><![CDATA[Biopharmaceutical quality and interchange of drugs]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodriguez-Saavedra]]></surname>
<given-names><![CDATA[Lennin]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cruz-Aranda]]></surname>
<given-names><![CDATA[Luis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cruz-Julca]]></surname>
<given-names><![CDATA[Claudia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Alva-Plasencia]]></surname>
<given-names><![CDATA[Pedro]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad Nacional Mayor de San Marcos Facultad de Medicina ]]></institution>
<addr-line><![CDATA[Lima ]]></addr-line>
<country>Peru</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad Nacional de Trujillo Facultad de Farmacia y Bioquímica Departamento de Farmacotecnia]]></institution>
<addr-line><![CDATA[Trujillo ]]></addr-line>
<country>Peru</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>09</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>09</month>
<year>2021</year>
</pub-date>
<volume>62</volume>
<numero>3</numero>
<fpage>315</fpage>
<lpage>327</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S2340-98942021000300315&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S2340-98942021000300315&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S2340-98942021000300315&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Introducción: La industria farmacéutica que busca la aprobación para comercializar un medicamento genérico debe presentar datos que demuestren que la formulación genérica proporciona la misma calidad, eficacia y seguridad que el medicamento innovador. Por lo tanto, la mayoría de los medicamentos genéricos administrados por vía oral están aprobados en función de los resultados de uno o más estudios fisicoquímicos y biofarmacéuticos para demostrar bioequivalencia y posterior intercambiabilidad.  Objetivo: Identificar en los artículos de investigación las posibles diferencias entre las pruebas fisicoquímicas y biofarmacéuticas de bioequivalencia de medicamentos genéricos con la de sus homólogos ya comercializados.  Método: Se realizó la revisión de estudios de investigación originales, publicados desde enero del año 2003 hasta diciembre del 2019. Se consultaron 4 bases de datos Pubmed, ScienceDirect, Lilacs, Scielo. En inglés y español. Los descriptores utilizados fueron medicamento genérico, bioequivalencia, equivalencia terapéutica e intercambialidad, así mismo solo se seleccionaron aquellos artículos donde su forma farmacéutica de estudio fuese comprimidos.  Resultados: Se seleccionaron en total 40 artículos para su evaluación, de los cuales 19 llegaron a la conclusión de bioequivalencia, otros 19 determinaron no bioequivalencia, para 1 no existía una conclusión definitiva, mientras que en 1 estudio que evaluaba a 3 medicamentos, la conclusión fue no bioequivalencia para 2 de ellos y para el tercero sí la había.  Conclusión: La revisión revela que los estudios son insuficientes para indicar bioequivalencia entre los fármacos multifuentes (genéricos) y los innovadores, por lo que se necesita ampliar los estudios de bioequivalencia.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Introduction:  The pharmaceutical industry seeking approval to market a generic drug must submit data demonstrating that the generic formulation provides the same quality, efficacy, and safety of the innovative drug. Therefore, most orally administered generic drugs are approved based on the results of one or more physicochemical and biopharmaceutical studies to demonstrate bioequivalence and subsequent interchangeability.  Objective:  Identify in research articles the possible differences between the physicochemical and biopharmaceutical tests of bioequivalence of generic drugs with that of their corresponding innovative equivalents.  Method:  The original research studies, published from January 2003 to December 2019, were reviewed. 4 databases were consulted Pubmed, ScienceDirect, Lilacs, Scielo. In English and Spanish. The descriptors used were generic medicine, bioequivalence, therapeutic equivalence and interchangeability, likewise only those articles where their study pharmaceutical form was tablets were selected.  Results:  A total of 40 articles were selected for evaluation, of which 19 reached the conclusion of bioequivalence, another 19 determined non-bioequivalence, for 1 there was no definitive conclusion, while in a study that evaluated 3 drugs, the conclusion was no bioequivalence for 2 of them and bioequivalence for one.  Conclusions: The review reveals that the studies are insufficient to indicate bioequivalence between multi-source (generic) and innovative drugs, so that bioequivalence studies need to be expanded.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Equivalencia terapéutica]]></kwd>
<kwd lng="es"><![CDATA[intercambiabilidad de medicamentos]]></kwd>
<kwd lng="es"><![CDATA[medicamento genérico]]></kwd>
<kwd lng="es"><![CDATA[medicamento de referencia]]></kwd>
<kwd lng="en"><![CDATA[Therapeutic equivalency]]></kwd>
<kwd lng="en"><![CDATA[interchangeability of Drug]]></kwd>
<kwd lng="en"><![CDATA[generic drug]]></kwd>
<kwd lng="en"><![CDATA[reference drugs]]></kwd>
</kwd-group>
</article-meta>
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