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

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Standard Standard

Acceptability of generic versus innovator oral medicines: not only a matter of taste. / Tuleu, C.; Hughes, Dyfrig; Clapham, David et al.
In: Drug Discovery Today, Vol. 26, No. 2, 02.2021, p. 329-343.

Research output: Contribution to journal › Article › peer-review

HarvardHarvard

Tuleu, C, Hughes, D, Clapham, D, Vallet, T & Ruiz, F 2021, 'Acceptability of generic versus innovator oral medicines: not only a matter of taste', Drug Discovery Today, vol. 26, no. 2, pp. 329-343. https://doi.org/10.1016/j.drudis.2020.11.008

APA

Tuleu, C., Hughes, D., Clapham, D., Vallet, T., & Ruiz, F. (2021). Acceptability of generic versus innovator oral medicines: not only a matter of taste. Drug Discovery Today, 26(2), 329-343. https://doi.org/10.1016/j.drudis.2020.11.008

CBE

Tuleu C, Hughes D, Clapham D, Vallet T, Ruiz F. 2021. Acceptability of generic versus innovator oral medicines: not only a matter of taste. Drug Discovery Today. 26(2):329-343. https://doi.org/10.1016/j.drudis.2020.11.008

MLA

Tuleu, C. et al. "Acceptability of generic versus innovator oral medicines: not only a matter of taste". Drug Discovery Today. 2021, 26(2). 329-343. https://doi.org/10.1016/j.drudis.2020.11.008

VancouverVancouver

Tuleu C, Hughes D, Clapham D, Vallet T, Ruiz F. Acceptability of generic versus innovator oral medicines: not only a matter of taste. Drug Discovery Today. 2021 Feb;26(2):329-343. Epub 2020 Nov 17. doi: https://doi.org/10.1016/j.drudis.2020.11.008

Author

Tuleu, C. ; Hughes, Dyfrig ; Clapham, David et al. / Acceptability of generic versus innovator oral medicines: not only a matter of taste. In: Drug Discovery Today. 2021 ; Vol. 26, No. 2. pp. 329-343.

RIS

TY - JOUR

T1 - Acceptability of generic versus innovator oral medicines: not only a matter of taste

AU - Tuleu, C.

AU - Hughes, Dyfrig

AU - Clapham, David

AU - Vallet, Thibault

AU - Ruiz, Fabrice

PY - 2021/2

Y1 - 2021/2

N2 - Optimum use of generic products would require equivalence, not only in terms of quality, safety and efficacy in clinical studies, but also patient acceptability in order not to jeopardize treatment success due to non-adherence which would de facto limit the potential cost saving anticipated by their use. Although acceptability is a requirement for the authorisation of paediatric innovator products, our survey of EU regulatory authorities uncovered 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 focus on unifying guidance for the development and scrutiny of generics should include acceptability alongside the other factors being considered for harmonization.

AB - Optimum use of generic products would require equivalence, not only in terms of quality, safety and efficacy in clinical studies, but also patient acceptability in order not to jeopardize treatment success due to non-adherence which would de facto limit the potential cost saving anticipated by their use. Although acceptability is a requirement for the authorisation of paediatric innovator products, our survey of EU regulatory authorities uncovered 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 focus on unifying guidance for the development and scrutiny of generics should include acceptability alongside the other factors being considered for harmonization.

KW - Generic

KW - Acceptability

KW - Palatibility

KW - Swallowability

KW - Appearance

KW - Cost Effectiveness

U2 - https://doi.org/10.1016/j.drudis.2020.11.008

DO - https://doi.org/10.1016/j.drudis.2020.11.008

M3 - Article

VL - 26

SP - 329

EP - 343

JO - Drug Discovery Today

JF - Drug Discovery Today

SN - 1359-6446

IS - 2

ER -