Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs

Transplant International

Volumn 26, Issue 8, 2013, Pages 771-777

  Van Gelder, Teun ^a   Gabardi, Steven ^b  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

bioequivalence; calcineurins antagonists; generics; immunosuppression; mycophenolat mofetil

Indexed keywords

CALCINEURIN INHIBITOR; CYCLOSPORIN; GENERIC DRUG; IMMUNOSUPPRESSIVE AGENT; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; TACROLIMUS;

AREA UNDER THE CURVE; BIOEQUIVALENCE; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG MARKETING; DRUG MONITORING; HUMAN; MAXIMUM PLASMA CONCENTRATION; ORGAN TRANSPLANTATION; PRIORITY JOURNAL; REVIEW; TIME TO MAXIMUM PLASMA CONCENTRATION;

BIOEQUIVALENCE; CALCINEURINS ANTAGONISTS; GENERICS; IMMUNOSUPPRESSION; MYCOPHENOLAT MOFETIL;

AREA UNDER CURVE; DRUG APPROVAL; DRUG MONITORING; DRUG SUBSTITUTION; DRUGS, GENERIC; EUROPE; FASTING; HEALTHY VOLUNTEERS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; THERAPEUTIC EQUIVALENCY; TRANSPLANTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84880270095     PISSN: 09340874     EISSN: 14322277     Source Type: Journal    
DOI: 10.1111/tri.12074     Document Type: Review

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