Generics in transplantation medicine: Randomized comparison of innovator and substitution products containing mycophenolate mofetil .
Journal
International journal of clinical pharmacology and therapeutics
ISSN: 0946-1965
Titre abrégé: Int J Clin Pharmacol Ther
Pays: Germany
ID NLM: 9423309
Informations de publication
Date de publication:
Oct 2019
Oct 2019
Historique:
accepted:
20
09
2019
pubmed:
10
8
2019
medline:
1
10
2019
entrez:
10
8
2019
Statut:
ppublish
Résumé
Mycophenolate mofetil (MMF) is widely used as an immunosuppressant for the prophylaxis of acute organ rejection in recipients of solid organ transplants. We have compared, in healthy subjects, the pharmacokinetics of mycophenolic acid when MMF was administered in the form of the innovator product CellCept (F. Hoffmann-La Roche Ltd.) or one of three commercially available generics, Renodapt (Biocon Ltd.), Mycept (Panacea Biotec), or Cellmune (Cipla Ltd.). The study was powered to detect a 20% difference in mean formulation performance measures, but not to formally evaluate bioequivalence. Geometric mean ratios of maximum concentrations (C Comparing generics against each other, the differences in point estimates of the geometric mean ratios of C Physicians in the field of transplantation should be aware of the potential risk of altering the therapeutic outcome when switching from one preparation of MMF to another. ClinicalTrials.gov identifier: NCT02981290.
Identifiants
pubmed: 31397274
pii: 185671
doi: 10.5414/CP203487
pmc: PMC6751510
doi:
Substances chimiques
Drugs, Generic
0
Immunosuppressive Agents
0
Mycophenolic Acid
HU9DX48N0T
Banques de données
ClinicalTrials.gov
['NCT02981290']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
506-519Références
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