<?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>0379-3982</journal-id>
<journal-title><![CDATA[Revista Tecnología en Marcha]]></journal-title>
<abbrev-journal-title><![CDATA[Tecnología en Marcha]]></abbrev-journal-title>
<issn>0379-3982</issn>
<publisher>
<publisher-name><![CDATA[Instituto Tecnológico de Costa Rica]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0379-39822016000100018</article-id>
<article-id pub-id-type="doi">10.18845/tm.v29i1.2535</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Oferta y demanda de estudios de equivalencia terapéutica (in vitro e in vivo) de medicamentos en Costa Rica]]></article-title>
<article-title xml:lang="en"><![CDATA[Offer and demand of therapeutic equivalence studies (in vitro and in vivo) for medicines in Costa Rica]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pereira-Vega]]></surname>
<given-names><![CDATA[Zacarías]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad de Costa Rica Facultad de Farmacia ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Costa Rica</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>03</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>03</month>
<year>2016</year>
</pub-date>
<volume>29</volume>
<numero>1</numero>
<fpage>18</fpage>
<lpage>27</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.sa.cr/scielo.php?script=sci_arttext&amp;pid=S0379-39822016000100018&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.sa.cr/scielo.php?script=sci_abstract&amp;pid=S0379-39822016000100018&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.sa.cr/scielo.php?script=sci_pdf&amp;pid=S0379-39822016000100018&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen El continuo incremento del gasto en medicamentos a nivel mundial, íntimamente asociado al crecimiento poblacional y al aumento de la esperanza de vida de las personas, ha llevado en las últimas décadas a los gobiernos a buscar alternativas que contribuyan a reducir el impacto de este rubro en los presupuestos. Una alternativa es el uso de medicamentos genéricos, que son más baratos que los innovadores. Sin embargo, antes de ser registrado, el producto genérico debe demostrar su equivalencia terapéutica mediante ensayos in vitro y/o in vivo contra un medicamento de referencia, con el propósito de garantizar su calidad, seguridad y eficacia y, como consecuencia de ello, su intercambiabilidad. Mediante una encuesta online realizada en Costa Rica durante los meses de marzo y abril de 2013, se determinó que existía una demanda de 85 medicamentos fabricados en el país, que para ser registrados a nivel nacional requerían de la misma cantidad de estudios de equivalencia terapéutica, de los cuales 47 correspondían a ensayos in vitro y 38 a ensayos in vivo. Esta demanda provenía principalmente de cuatro laboratorios que fabrican medicamentos en Costa Rica, y aumenta si se consideran los medicamentos exportados. En cuanto a la oferta nacional de estos servicios (ensayos in vitro e in vivo) por parte de laboratorios ajenos a la casa fabricante, se sabe que es muy limitada, ya que solo había dos que los ofertaban y su labor se circunscribe, por ahora, a los ensayos in vitro.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract In the last decades the constant increase of medicine expenses worldwide, as well as the population growth and the increase of life expectancy, has led governments to look for alternatives to help reduce the impact of this matter in their budgets. Generic medicines are one option because they are cheaper than originator medicines. Nevertheless, the generic medicine must prove its therapeutic equivalence, before its registration, by undergoing in vitro and/or in vivo essays compared to a reference medicine to guarantee its quality, safety and efficacy; and, thus, its interchangeability. An on line survey executed in March and April, 2013, helped determine there was a demand for 85 medicines produced in Costa Rica that, to be registered in the country, required the same amount of therapeutic equivalence studies; 47 required in vitro essays and 38 required in vivo essays. This demand came mainly from four laboratories that produce medicines in the country; it increases if exported medicines are included. Regarding the national offer of these services (in vitro and in vivo essays) from laboratories that do not belong to the producer, it is well known that this is very limited, since there were only two laboratories offering the service, and their work is limited, for now, to in vitro essays.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Laboratorio fabricante de medicamentos]]></kwd>
<kwd lng="es"><![CDATA[estudios de equivalencia terapéutica de medicamentos]]></kwd>
<kwd lng="es"><![CDATA[intercambiabilidad]]></kwd>
<kwd lng="es"><![CDATA[medicamento genérico]]></kwd>
<kwd lng="es"><![CDATA[medicamento innovador]]></kwd>
<kwd lng="es"><![CDATA[bioexención]]></kwd>
<kwd lng="es"><![CDATA[medicamento de riesgo sanitario]]></kwd>
<kwd lng="en"><![CDATA[Medicine manufacturing laboratory]]></kwd>
<kwd lng="en"><![CDATA[therapeutic equivalence study for medicines]]></kwd>
<kwd lng="en"><![CDATA[interchangeability]]></kwd>
<kwd lng="en"><![CDATA[generic]]></kwd>
<kwd lng="en"><![CDATA[originator]]></kwd>
<kwd lng="en"><![CDATA[biowaiver]]></kwd>
<kwd lng="en"><![CDATA[sanitary risk medicine]]></kwd>
</kwd-group>
</article-meta>
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