Evaluation of Clinical and Safety Outcomes Associated with Conversion from Brand-Name to Generic Tacrolimus in Transplant Recipients Enrolled in an Integrated Health Care System

Author:

Spence Michele M.1,Nguyen Lynda M.2,Hui Rita L.3,Chan James3

Affiliation:

1. Pharmacy Outcomes Research Group; Kaiser Permanente; Downey; California

2. Department of Pharmacy; San Francisco Veterans Affairs Medical Center; San Francisco; California

3. Pharmacy Outcomes Research Group; Kaiser Permanente; Oakland; California

Publisher

Wiley

Subject

Pharmacology (medical)

Reference20 articles.

1. U.S. Food and Drug Administration Approved drug products http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory

2. U.S. Food and Drug Administration Orange Book: approved drug products with therapeutic equivalence evaluations. Tacrolimus http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No = 065461&TABLE

3. U.S. Food and Drug Administration Drugs@FDA glossary of terms. Therapeutic equivalence http://www.fda.gov/Drugs/informationondrugs/ucm079436.htm#T

4. Generic tacrolimus: lack of bioequivalence data in transplant recipients raises concerns;Hogan;Nephrol Times,2009

5. Transplant pharmacists' opinion on generic product selection of critical-dose drugs;Vasquez;Am J Health-Syst Pharm,1999

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