Real-life Bioequivalence of Tacrolimus in Patients With Living-Related Donor De Novo Renal Transplantation: An Observational Study.
Journal
Transplantation proceedings
ISSN: 1873-2623
Titre abrégé: Transplant Proc
Pays: United States
ID NLM: 0243532
Informations de publication
Date de publication:
Historique:
received:
30
12
2019
revised:
13
03
2020
accepted:
19
03
2020
pubmed:
26
5
2020
medline:
15
12
2020
entrez:
26
5
2020
Statut:
ppublish
Résumé
Tacrolimus is a narrow therapeutic index drug. As a result, regulatory agencies worldwide recommend stringent bioequivalence evaluation criteria for approval of generics. Despite this, the professional transplantation societies have raised concerns over the safety and efficacy of generic substitutions. We conducted this pragmatic real-life bioequivalence study to assess the effect of generic substitutions of tacrolimus. This was an observational study including recipients of renal transplantation who were considered for generic medication substitution. Transplanted organs were from living-related donors and were performed at least 1 month before the study. Time of administration of the drug, time of dosing with respect to meals, and time of blood sample collection were controlled; however, the lot number of the generic drugs was not controlled. The participants were allowed to use their usual supplies irrespective of the lot number. Concentration (C
Identifiants
pubmed: 32448656
pii: S0041-1345(19)31738-5
doi: 10.1016/j.transproceed.2020.03.017
pii:
doi:
Substances chimiques
Drugs, Generic
0
Immunosuppressive Agents
0
Tacrolimus
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Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1715-1717Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.