Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx

Hdl Handle:
http://hdl.handle.net/10144/315987
Title:
Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx
Authors:
Gaspani, Sara
Journal:
Generics and Biosimilars Initiative Journal
Abstract:
The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval of the first generic liposomal product by the US Food and Drug Administration in February 2013 could be a turning point, and serve as a basis for WHO to develop guidance for the evaluation of generic liposomal formulations.
Publisher:
Pro Pharma Communications International
Issue Date:
18-Apr-2014
URI:
http://hdl.handle.net/10144/315987
DOI:
10.5639/gabij.2013.0202.022
Additional Links:
http://www.gabi-journal.net/access-to-liposomal-generic-formulations-beyond-ambisome-and-doxilcaelyx.html
Language:
en
Description:
To access this article, click on "Additional Links".
ISSN:
20336403; 20336772
Appears in Collections:
Health Politics

Full metadata record

DC FieldValue Language
dc.contributor.authorGaspani, Saraen_GB
dc.date.accessioned2014-04-18T13:16:36Z-
dc.date.available2014-04-18T13:16:36Z-
dc.date.issued2014-04-18-
dc.identifier.citationAccess to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx 2013, 2 (2):60 Generics and Biosimilars Initiative Journalen_GB
dc.identifier.issn20336403-
dc.identifier.issn20336772-
dc.identifier.doi10.5639/gabij.2013.0202.022-
dc.identifier.urihttp://hdl.handle.net/10144/315987-
dc.descriptionTo access this article, click on "Additional Links".en_GB
dc.description.abstractThe lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval of the first generic liposomal product by the US Food and Drug Administration in February 2013 could be a turning point, and serve as a basis for WHO to develop guidance for the evaluation of generic liposomal formulations.en_GB
dc.language.isoenen
dc.publisherPro Pharma Communications Internationalen_GB
dc.relation.urlhttp://www.gabi-journal.net/access-to-liposomal-generic-formulations-beyond-ambisome-and-doxilcaelyx.htmlen_GB
dc.rightsArchived with thanks to Generics and Biosimilars Initiative Journalen_GB
dc.subjectHealth Policy/Access to Medecinesen_GB
dc.subjectKala Azar/Visceral Leishmaniasisen_GB
dc.titleAccess to liposomal generic formulations: beyond AmBisome and Doxil/Caelyxen
dc.identifier.journalGenerics and Biosimilars Initiative Journalen_GB
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