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Acceptability of generic versus innovator oral medicines: not only a matter of taste

Tuleu, C; Hughes, DA; Clapham, D; Vallet, T; Ruiz, F; (2020) Acceptability of generic versus innovator oral medicines: not only a matter of taste. Drug Discovery Today 10.1016/j.drudis.2020.11.008. (In press).

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Abstract

Optimum use of generic products would require equivalence, not only in terms of quality, safety, and efficacy in clinical studies, but also patient acceptability to not jeopardize treatment success because of nonadherence which would de facto limit the potential cost saving anticipated by their use. Although acceptability is a requirement for the authorization of pediatric innovator products, our survey of European Union (EU) regulatory authorities showed that few have a formal process for assessing patient acceptability of generic products during the registration processes. The current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focus on unifying guidance for the development and scrutiny of generics but should include acceptability alongside the other factors being considered for harmonization.

Type: Article
Title: Acceptability of generic versus innovator oral medicines: not only a matter of taste
DOI: 10.1016/j.drudis.2020.11.008
Publisher version: https://doi.org/10.1016/j.drudis.2020.11.008
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics
URI: https://discovery.ucl.ac.uk/id/eprint/10115422
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