Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Christoph Baumgärtel, Brian Godman

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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 languageEnglish
Number of pages3
JournalGenerics and Biosimilars Initiative journal
Volume4
Issue number4
Early online date2 Nov 2015
Publication statusE-pub ahead of print - 2 Nov 2015

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Keywords

  • bioequivalence
  • ciclosporine
  • EMA
  • generics
  • immunosuppressives
  • narrow therapeutic index drugs

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