Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Christoph Baumgärtel; Brian Godman

Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Christoph Baumgärtel, Brian Godman

Strathclyde Institute Of Pharmacy And Biomedical Sciences

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

4 Citations (Scopus)

101 Downloads (Pure)

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 ciclosporine despite being on the market in Europe for more than 10 years

Original language	English
Number of pages	3
Journal	Generics and Biosimilars Initiative journal
Volume	4
Issue number	4
Early online date	2 Nov 2015
Publication status	E-pub ahead of print - 2 Nov 2015

Keywords

bioequivalence
ciclosporine
EMA
generics
immunosuppressives
narrow therapeutic index drugs

Access to Document

Baumgärtel-Godman-GABIJ-2015-Bioequivalence-of-narrow-therapeutic-index-drugs-andAccepted author manuscript, 338 KB

Cite this

@article{4ab3bfa913be4c0588bea63dd2333e0a,

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 ciclosporine despite being on the market in Europe for more than 10 years",

keywords = "bioequivalence, ciclosporine, EMA, generics, immunosuppressives, narrow therapeutic index drugs",

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

year = "2015",

month = nov,

day = "2",

language = "English",

volume = "4",

journal = "Generics and Biosimilars Initiative journal",

issn = "2033-6403",

number = "4",

}

TY - JOUR

T1 - Bioequivalence of narrow therapeutic index drugs and immunosuppressives

AU - Baumgärtel, Christoph

AU - Godman, Brian

PY - 2015/11/2

Y1 - 2015/11/2

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 ciclosporine 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 ciclosporine despite being on the market in Europe for more than 10 years

KW - bioequivalence

KW - ciclosporine

KW - EMA

KW - generics

KW - immunosuppressives

KW - narrow therapeutic index drugs

UR - http://gabi-journal.net/

UR - http://gabi-journal.net/bioequivalence-of-narrow-therapeutic-index-drugs-and-immunosuppressives.html

M3 - Article

SN - 2033-6403

VL - 4

JO - Generics and Biosimilars Initiative journal

JF - Generics and Biosimilars Initiative journal

IS - 4

ER -

Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this