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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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<strong>Instituto</strong> <strong>de</strong> <strong>Salud</strong> <strong>Pública</strong> <strong>de</strong> <strong>Chile</strong>”<br />

ICH, 2000. International Conference on Harmonization; Guidance on Q<br />

6A Specifications: Tests Procedures and Acceptance Criteria for New<br />

Drug Substances and New Drug Products: Chemical Substances,<br />

Fe<strong>de</strong>ral Register 65 (251)<br />

ICH, 2005. Validation of Analytical Procedures: Text and Methodology<br />

Q2 (R1). International Conference on Harmonization of Technical<br />

Requirements<br />

Jantratid, E., Prakongpan, S., Dressman, J. B., Amidon, G. L.,<br />

Junginger, H. E., Midha, K. K., Barends, D. M. Biowaiver Monographs<br />

for Immediate Release Solid Oral Dosage Forms: Cimetidine. J. Pharm.<br />

Sci. 95 (5), 974 – 948, 2006<br />

Jantratid, E., Prakongpan, S., Dressman, J. B., Amidon, G. L.,<br />

Junginger, H. E., Midha, K. K., Barends, D. M. Biowaiver Monographs<br />

for Immediate Release Solid Oral Dosage Forms: Cimetidine. J. Pharm.<br />

Sci. 95 (5), 974 – 948, 2006<br />

Jung H., Validación <strong>de</strong> Métodos Analíticos para estudios <strong>de</strong> Perfiles <strong>de</strong><br />

Liberación-Disolución. En: Curso Biofarmacia 1 (BP1). Universidad <strong>de</strong><br />

Costa Rica, Septiembre, 2006<br />

Kalantzi, L., Reppas, C., Dressman, J. B., Dressman, J. B., Amidon, G.<br />

L., Junginger, H. E., Midha, K. K., Shah, V. P., Stavchansky, S. A.,<br />

Barends, D. M., Biowaiver Monographs for Immediate Release Solid<br />

Oral Dosage Forms: Acetaminophen (Paracetamol). J. Pharm. Sci. 95<br />

(1), 4 – 14, 2006.<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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