De novouse of a generic formulation of tacrolimus versus reference tacrolimus in kidney transplantation: evaluation of the clinical results, histology in protocol biopsies, and immunological monitoring

Author:

Melilli Edoardo1,Crespo Elena2,Sandoval Diego1,Manonelles Anna12,Sala Neus1,Mast Richard3,Padulles Ariadna4,Grinyo Josep M.1,Bestard Oriol12,Cruzado Josep Maria12

Affiliation:

1. Bellvitge University Hospital; Department of Nephrology; Renal Transplantation Unit carrer de la feixa llarga L'Hospitalet de Llobregat; Barcelona Spain

2. IDIBELL; Department of Experimental Nephrology; Carrer de la feixa llarga L'Hospitalet de Llobregat; Barcelona Spain

3. Department of Radiology; Bellvitge University Hospital; Carrer de la feixa llarga L'Hospitalet de Llobregat; Barcelona Spain

4. Department of Pharmacy; Bellvitge University Hospital; Carrer de la feixa llarga L'Hospitalet de Llobregat; Barcelona Spain

Funder

Spanish Government

Publisher

Frontiers Media SA

Subject

Transplantation

Reference25 articles.

1. Immunosuppression, generic drugs and the FDA;Klintmalm;Am J Transplant,2011

2. Response to Klintmalm on the use of generic immunosuppression;Latran;Am J Transplant,2012

3. Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation;Johnston;Eur J Hosp Pharm,2013

4. The ongoing regulation of generic drugs;Frank;N Engl J Med,2007

5. US Department of Health and Human Services FDA CDER Guidance for Industry. Bioavailability and Bioequivalence. Studies for Orally Administered Drug Products - General Considerations 2003

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