Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Brian Godman; Christoph Baumgärtel

doi:10.5639/gabij.2015.0403.035

Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Brian Godman
, Christoph Baumgärtel

Karolinska Institutet
Austrian Agency for Health and Food Safety GmbH

Research output: Contribution to journal › Comment/debate

4 Scopus citations

Abstract

Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market in Europe for more than 10 years.

Original language	English
Pages (from-to)	159-160
Number of pages	2
Journal	GaBI Journal
Volume	4
Issue number	4
DOIs	https://doi.org/10.5639/gabij.2015.0403.035
State	Published - 2015
Externally published	Yes

Keywords

Bioequivalence
Ciclosporin
EMA
Generics
Immunosuoppressives
Narrow therapeutic index drugs

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10.5639/gabij.2015.0403.035

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title = "Bioequivalence of narrow therapeutic index drugs and immunosuppressives",

abstract = "Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market in Europe for more than 10 years.",

keywords = "Bioequivalence, Ciclosporin, EMA, Generics, Immunosuoppressives, Narrow therapeutic index drugs",

author = "Brian Godman and Christoph Baumg{\"a}rtel",

note = "Publisher Copyright: {\textcopyright} 2015 Pro Pharma Communications International.",

year = "2015",

doi = "10.5639/gabij.2015.0403.035",

language = "English",

volume = "4",

pages = "159--160",

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T1 - Bioequivalence of narrow therapeutic index drugs and immunosuppressives

AU - Godman, Brian

AU - Baumgärtel, Christoph

PY - 2015

Y1 - 2015

N2 - Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market in Europe for more than 10 years.

AB - Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market in Europe for more than 10 years.

KW - Bioequivalence

KW - Ciclosporin

KW - EMA

KW - Generics

KW - Immunosuoppressives

KW - Narrow therapeutic index drugs

UR - https://www.scopus.com/pages/publications/85008253557

U2 - 10.5639/gabij.2015.0403.035

DO - 10.5639/gabij.2015.0403.035

M3 - Comment/debate

AN - SCOPUS:85008253557

SN - 2033-6403

VL - 4

SP - 159

EP - 160

JO - GaBI Journal

JF - GaBI Journal

IS - 4

ER -

Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Abstract

Keywords

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