Éditeur(s) : HAL CCSD
Résumé : International audience
Given the clinical success of commercial amphotericin B lipid products, investigators have begun making generic formulations of liposomal amphotericin B. Generic medicines are an attractive approach to help decrease the cost and accessibility to healthcare, provided that appropriate studies are performed to ensure bioequivalence with the parent product. This is of particular concern for liposomal drugs such as amphotericin B where liposomes are used as a carrier system to reduce the toxicity of the active agent. A favorable therapeutic profile for this form of the drug has to include the proper chemical composition along with strictly controlled manufacturing processes. Studies have shown that a comparison of liposomal amphotericin B products with different or the same chemical compositions, using different methods of production, will vary in size, and have significantly dissimilar in vitro and in vivo toxicities along with reduced efficacy. These results underscore the importance of establishing appropriate bioequivalence testing for liposome products to ensure uniformity of their therapeutic index
Medical Mycology

hal-01259233
https://hal-univ-rennes1.archives-ouvertes.fr/hal-01259233
DOI : 10.1093/mmy/myv111
PUBMED : 26768369

Éditeur(s) : HAL CCSD IOS Press
Résumé : International audience
This document, supported by both the International Society for Clinical Hemorheology and the European Society for Clinical Hemorheology and Microcirculation, proposes new guidelines for hemorheological methods used in experimental and clinical studies. It is based on a similar document entitled: "Guidelines for measurement of blood viscosity and erythrocyte deformability" published in 1986 by the Expert Panel on Blood Rheology of the International Committee for Standardization in Hematology. Recent methods, techniques and instruments, as well as new approaches to interpretation of results, are added to these new guidelines; wide spread adoption should improve comparability between hemorheological laboratories and increase the reliability of rheological tests.
ISSN: 1386-0291

hal-00709840
https://hal.archives-ouvertes.fr/hal-00709840
https://hal.archives-ouvertes.fr/hal-00709840/document
https://hal.archives-ouvertes.fr/hal-00709840/file/New_Guidelines_accepted_1-4-2009.pdf