GUÍA TÉCNICA G-BIOF 02: - Instituto de Salud Pública de Chile
GUÍA TÉCNICA G-BIOF 02: - Instituto de Salud Pública de Chile
GUÍA TÉCNICA G-BIOF 02: - Instituto de Salud Pública de Chile
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
<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 />
58