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Assessing the safety and cost-effectiveness of early nanodrugs

Vines, Timothy; Faunce, Thomas

Description

This article provides a detailed examination of how the safety and cost-effectiveness elements of Australia's drug regulatory system will respond to nanomedicines. The case study investigated involves Abraxane, a newly developed anti-cancer agent. The article concludes by proposing some responses to the challenges which nanomedicines are likely to present to international and domestic agencies. Additionally, it considers whether the recommendation of the Australian Productivity Commission to...[Show more]

dc.contributor.authorVines, Timothy
dc.contributor.authorFaunce, Thomas
dc.date.accessioned2015-12-07T22:24:53Z
dc.identifier.issn1320-159X
dc.identifier.urihttp://hdl.handle.net/1885/21027
dc.description.abstractThis article provides a detailed examination of how the safety and cost-effectiveness elements of Australia's drug regulatory system will respond to nanomedicines. The case study investigated involves Abraxane, a newly developed anti-cancer agent. The article concludes by proposing some responses to the challenges which nanomedicines are likely to present to international and domestic agencies. Additionally, it considers whether the recommendation of the Australian Productivity Commission to allow parallel submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) and the Therapeutic Goods Administration (TGA) is appropriate when applied to new nanotherapeutics.
dc.publisherThe Law Book Company
dc.rightsCopyright Lawbook Co. This publication is copyright. Other than for the purposes of and subject to the conditions prescribed under the Copyright Act 1968 (Cth), no part of it may in any form or by any means (electronic, mechanical, microcopying, photocopying, recording or otherwise) be reproduced, stored in a retrieval system or transmitted without prior written permission. Enquiries should be addressed to Thomson Reuters (Professional) Australia Limited.
dc.sourceJournal of Law and Medicine
dc.subjectKeywords: drug; nanoparticle; article; Australia; chemistry; cost benefit analysis; drug legislation; human; pharmaceutics; Australia; Cost-Benefit Analysis; Humans; Legislation, Drug; Nanoparticles; Pharmaceutical Preparations; Technology, Pharmaceutical
dc.titleAssessing the safety and cost-effectiveness of early nanodrugs
dc.typeJournal article
local.description.notesImported from ARIES
local.identifier.citationvolume16
dc.date.issued2009
local.identifier.absfor180199 - Law not elsewhere classified
local.identifier.absfor119999 - Medical and Health Sciences not elsewhere classified
local.identifier.ariespublicationu4046278xPUB15
local.type.statusPublished Version
local.contributor.affiliationFaunce, Thomas, ANU College of Law, ANU
local.contributor.affiliationVines, Timothy, ANU College of Law, ANU
local.bibliographicCitation.startpage822
local.bibliographicCitation.lastpage845
local.identifier.absseo949999 - Law, Politics and Community Services not elsewhere classified
local.identifier.absseo929999 - Health not elsewhere classified
dc.date.updated2016-02-24T10:31:00Z
local.identifier.scopusID2-s2.0-77955861453
dcterms.accessRightsOpen Access
dc.provenanceThe permission to archive the version was archived in ERMS2988179. This article was first published by Thomson Reuters in the Journal of Law and Medicine and should be cited as "Faunce, Thomas Alured, and Timothy Vines. "Assessing the Safety and Cost-Effectiveness of Early Nanodrugs." (2009). Journal of Law and Medicine, Vol. 16, p. 822-845". For all subscription inquiries please phone, from Australia: 1300 304 195, from Overseas: +61 2 8587 7980 or online at legal.thomsonreuters.com.au/search. The official PDF version of this article can also be purchased separately from Thomson Reuters at http://sites.thomsonreuters.com.au/journals/subscribe-or-purchase
CollectionsANU Research Publications

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