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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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Reforma <strong>de</strong> la <strong>Salud</strong>. Ministerio <strong>de</strong> <strong>Salud</strong> <strong>de</strong> <strong>Chile</strong>. 2004<br />

Resolución Exenta Nº 726: Listas <strong>de</strong> principios activos contenidos en<br />

productos farmacéuticos que <strong>de</strong>ben establecer equivalencia terapéutica<br />

mediante estudios in vivo o in vitro (bioexenciones). Ministerio <strong>de</strong> <strong>Salud</strong><br />

<strong>de</strong> <strong>Chile</strong>. 2005<br />

Resolución Exenta Nº 727: Norma que <strong>de</strong>fine Criterios para establecer<br />

Equivalencia Terapéutica a productos farmacéuticos en <strong>Chile</strong>. Gobierno<br />

<strong>de</strong> <strong>Chile</strong>. Ministerio <strong>de</strong> <strong>Salud</strong>. <strong>Instituto</strong> <strong>de</strong> <strong>Salud</strong> <strong>Pública</strong> <strong>de</strong> <strong>Chile</strong>, 2005<br />

Shah, V. P. Tsong, Y. Sathe, P. Liu, J - P., In vitro dissolution profile<br />

comparison–statistics and analysis of the similarity factor ƒ2. Pharm.<br />

Res. 15, 889 – 896. 1998<br />

Shah VP, Tsong Y, Sathe P., Liu JP. In vitro dissolution profile<br />

comparison-statistics and analysis of the similarity factor f2. Pharm.<br />

Res. 15: 889-896, 1998<br />

Shah Vinod P., Ph. D. Extending the Role of Dissolution in Regulatory<br />

Drug Product Bioequivalence. Curso Internacional: Biodisponibilidad y<br />

Bioequivalencia <strong>de</strong> Medicamentos. En 8º Congreso Argentino <strong>de</strong>l<br />

Medicamento. Mar <strong>de</strong>l Plata - Argentina, 1-2 Octubre 2004<br />

Siewert, M. Dressman, J. Brown, C. Shah, V. P. Williams, R. FIP/AAPS<br />

Guidance for dissolution / in vitro release testing of novel / special<br />

dosage forms. Dissolution technol. 10 (15), 10 – 13, 2003<br />

Sni<strong>de</strong>r, D.; Addicks, W.; Owens, W. Polymorphism in Generic Drug<br />

Product Development. Adv Drug Del Rev 56, 391-395, 2004<br />

Stephens R.H.; O’Neill, C.A.; Warhurst A.; Carlson G.L.; Rowland M.;<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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