Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Brian Godman*, Christoph Baumgärtel

*Corresponding author for this work

Research output: Contribution to journalComment/debate

1 Citation (Scopus)

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 languageEnglish
Pages (from-to)159-160
Number of pages2
JournalGaBI Journal
Volume4
Issue number4
DOIs
Publication statusPublished - 2015
Externally publishedYes

Keywords

  • Bioequivalence
  • Ciclosporin
  • EMA
  • Generics
  • Immunosuoppressives
  • Narrow therapeutic index drugs

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