Immunosuppression, generic drugs and the FDA

American Journal of Transplantation

Volumn 12, Issue 3, 2012, Pages 792-793

  Trofe Clark, J ^a,b   Gabardi, S ^c,d   McDevitt Potter, L ^e,f   Alloway, R R ^g  

^a HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

^e TUFTS MEDICAL CENTER   (United States)

^f TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF CINCINNATI   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCINEURIN INHIBITOR; GENERIC DRUG; TACROLIMUS;

BIOEQUIVALENCE; CLINICAL PRACTICE; COST CONTROL; DRUG BLOOD LEVEL; FOOD AND DRUG ADMINISTRATION; GRAFT REJECTION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY FUNCTION; LETTER; LIVER FUNCTION; PRIORITY JOURNAL;

DRUGS, GENERIC; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; LIVER TRANSPLANTATION; MALE; TACROLIMUS;

EID: 84857651758     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2011.03875.x     Document Type: Letter

References (5)

1. Klintmalm GB,. Immunosuppression,generic drugs and the FDA. Am J Transplant 2011; 11: 1765-1766.
2. Alloway R, Isaacs R, Lake K, et al,. Report of the AST conference on immunosuppressive drugs and the use of generic immunosuppressants. Am J Transplant 2003; 3: 1211-1215. (Pubitemid 37214617)
3. Center for Drug Evaluation and Research guidance for industry: Statistical approaches for establishing bioequivalence. 2001. Available at:. Accessed September 5, 2011.
4. Ensor CR, Trofe-Clark J, Gabardi S, Mc-Devitt-Potter LM, Shullo MA,. Generic maintenance immunosuppression in solid organ transplant recipients. Pharmacotherapy 2011; 31: 1111-1129.
5. McDevitt-Potter LM, Sadaka B, Tichy EM, Rogers CC, Gabardi S,. A multicenter experience with generic tacrolimus conversion. Transplantation 2011; 92: 653-657.