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Assessing the safety and cost-effectiveness of early nanodrugs

Date

2009

Authors

Vines, Timothy
Faunce, Thomas

Journal Title

Journal ISSN

Volume Title

Publisher

The Law Book Company

Abstract

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 allow parallel submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) and the Therapeutic Goods Administration (TGA) is appropriate when applied to new nanotherapeutics.

Description

Keywords

Keywords: drug; nanoparticle; article; Australia; chemistry; cost benefit analysis; drug legislation; human; pharmaceutics; Australia; Cost-Benefit Analysis; Humans; Legislation, Drug; Nanoparticles; Pharmaceutical Preparations; Technology, Pharmaceutical

Citation

Source

Journal of Law and Medicine

Type

Journal article

Book Title

Entity type

Access Statement

Open Access

License Rights

DOI

Restricted until