Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Baumgärtel, Christoph and Godman, Brian (2015) Bioequivalence of narrow therapeutic index drugs and immunosuppressives. Generics and Biosimilars Initiative journal, 4 (4). ISSN 2033-6403

[img]
Preview
Text (Baumgärtel-Godman-GABIJ-2015-Bioequivalence-of-narrow-therapeutic-index-drugs-and)
Baumg_rtel_Godman_GABIJ_2015_Bioequivalence_of_narrow_therapeutic_index_drugs_and.pdf
Accepted Author Manuscript

Download (346kB)| Preview

    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