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
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Kortejärvi, M. Yliperttula, M., Dressman, J. B., Junginger, H. E., Midha,<br />
K. K., Shah, V. P., Barends, D. M. Biowaiver Monographs for Immediate<br />
Release Solid Oral Dosage Forms: Ranitidine Hydrochlori<strong>de</strong>. J. Pharm.<br />
Sci. 94 (8), 1617 – 1625, 2005<br />
Le Cluyse E. and Sutton, S. In vitro mo<strong>de</strong>ls for selection of <strong>de</strong>velopment<br />
candidates. Permeability Studies to <strong>de</strong>fined mechanisms of absorption<br />
enhancement. Adv. Drug Del. Rev., 23:163-183, 1997<br />
Lentz, K. A. Hayashi, J. Lucisano, L. J. Polli; J. E. Development of a<br />
more rapid, reduced serum culture system for caco–2 monolayers and<br />
application to the biopharmaceutics classification system. Int. J. Pharm.<br />
200, 41 – 51, 20<strong>02</strong>.<br />
Liebenberg W. y cols. I<strong>de</strong>ntification of the Mebendazole Polymorphic<br />
Form present in Raw Materials and Tablets Available in South Africa.<br />
Drug Dev Ind Pharm 24 (5) 485-488, 1998<br />
Lin<strong>de</strong>nberg, M. Koop, S. Dressman, J. B. Classification of orally<br />
administered drugs on the World Health Organization Mo<strong>de</strong>l list of<br />
Essential Medicines according to the biopharmaceutics classification<br />
system. Eur. J. Pharm. Biopharm., 58, 265 – 278, 2004<br />
Löbenberg, R. Amidon, G. L. Mo<strong>de</strong>rn bioavailability, bioequivalence and<br />
biopharmaceutics classification system. New scientific approaches to<br />
international regulatory standards. Eur. J. Pharm. Biopharm. 50, 3 – 12,<br />
2000<br />
NIHS, 1997. Gui<strong>de</strong>line for bioequivalence Studies of Generic Products.<br />
National Institute of Health Sciences, Japan,<br />
http://www.nihs.go.jp/drug/be-gui<strong>de</strong>(e)/generic/be97E.html.<br />
Av. Marathón 1000 – Ñuñoa – Casilla 48 – Santiago – Teléfono: 350 74 77 – Código Postal: 7780050 – www.ispch.cl<br />
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