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GUÍA TÉCNICA G-BIOF 02: - Instituto de Salud Pública de Chile

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guts technique yielding realistic absorption rate. J. Pharm. Sci., 58(10):<br />

1196-1199, 1969<br />

EMEA,1998. (European Agency for the Evaluation of Medicinal<br />

Products), Note for Guidance on the Investigation of Bioavailability and<br />

Bioequivalence. Committee for Proprietary Medicinal Products<br />

(CPMP/EWP/QWP/1401/98)<br />

EMEA, 2001. Note for Guidance on the Investigation of Bioavailability<br />

and Bioequivalence. Committee for Proprietary Medicinal Products<br />

http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf<br />

Fan <strong>de</strong> Waterbeend H. Fundamental Variables of the Biopharmaceutics<br />

Classification System (BCS: A Commentary). European Journal of<br />

Pharmaceutical Sciences., Vol 7: 1-3, 1998<br />

Farmacopea <strong>de</strong> los Estados Unidos <strong>de</strong> América-Formulario Nacional. .<br />

Volumen 1, páginas 303; 586; 600; 638; 886; 1088. The United States<br />

Pharmacopeia Convention Inc, 2007<br />

FDA 1987. Guía para la Industria: Submitting Documentation for the<br />

Stability of Human Drugs and Biologics, USA<br />

FDA. 1987. Gui<strong>de</strong>line on General Principles of Process Validation. US<br />

Food and Drug Administration, Center for Drug Evaluation and<br />

Research, USA<br />

FDA, 1992. Co<strong>de</strong> of Fe<strong>de</strong>ral Regulations. 21CFR320.1. US Food and<br />

Drug Administration, Department of Health and Human Services. Drugs<br />

for Human Use Bioavailability and Bioequivalence Requirements<br />

FDA, 1993. Guía para inspecciones <strong>de</strong> laboratorios <strong>de</strong> Control <strong>de</strong><br />

Av. Marathón 1000 – Ñuñoa – Casilla 48 – Santiago – Teléfono: 350 74 77 – Código Postal: 7780050 – www.ispch.cl<br />

G-<strong>BIOF</strong>-<strong>02</strong><br />

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