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

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

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Calidad Farmacéutica. Center for Drug Evaluation and Research, USA<br />

FDA, 1997. Guidance for Industry: Dissolution Testing of Immediate<br />

Release Solid Oral Dosage Forms, US Center for Drug Evaluation and<br />

Research , USA<br />

FDA, 2000. Guidance for industry: Waiver of In Vivo Bioavailability and<br />

Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms<br />

based on Biopharmaceutics Classification System. US Food and Drug<br />

Administration, Center for Drug Evaluation and Research, USA<br />

FDA, 2003. Guidance for Industry: Bioavailability and Bioequivalence<br />

Studies for Orally Administered Drug Products– General Consi<strong>de</strong>rations.<br />

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

Research<br />

Giarcovich, S.S., Genéricos, Similares y el problema <strong>de</strong> la<br />

intercambiabilidad. Rev. SAFYBI 40 (101): 3-20, 2001<br />

Global Harmonization Task Force (GHTF). Quality Management<br />

Systems- Process Validation Guidance N 99-10, 2004<br />

Graffner, C. Regulatory aspects of drugs dissolution from a European<br />

perspective. Eur. J. Pharm Sci., 29, 288 – 293, 2006<br />

Gupta E., Barends D., Yamashita E., Lentz K. Armes A., Shah V.,<br />

Dressman J., Lipper R.. Review of global regulations concerning<br />

biowaivers for immediate release solid oral dosage forms. Eur. J.Pharm.<br />

Sci. 29: 315-324, 2006<br />

ISP, 2003. Resolución Exenta Nº 1575 (05/09/2007): “Modifica<br />

Denominación y Estructura Interna <strong>de</strong> los Departamentos que indica <strong>de</strong>l<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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