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                    <span style="font-size:14px;">ICH Q8 Parte 1</span><br/>
                    From: <a href="http://www.slideshare.net/asinfernando/">asinfernando</a>, 5 months ago<br /><br />
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ICH Q8 Parte 1

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Slide 1: ICH Q8 PHARMACEUTICAL DEVELOPMENT 1ª PARTE Fernando Tazón Álvarez Abril 2008

Slide 2: ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL DEVELOPMENT Q8 Status : Step 5 November 2005 Fernando Tazón Álvarez Abril 2008

Slide 3: INTRODUCCIÓN OBJETIVOS Describe el contenido de sección 3.2.P.2 (Desarrollo Farmacéutico) del formato CTD SE BUSCA: Demostrar el conocimiento del producto y de su proceso de fabricación Indicar áreas donde el demostrar comprensión científica puede crear las bases para la flexibilidad regulatoria El grado de esa flexibilidad regulato

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