Bioequivalence of a new strength tacrolimus capsule under development

Transplantation Proceedings

Volumn 30, Issue 4, 1998, Pages 1457-1459

  Bekersky, I ^a   Dressler, D ^b   Boswell, G W ^b   Fergen, B ^b   Tracewell, W ^b   Mekki, Q ^b  

^a ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

TACROLIMUS;

ADULT; AREA UNDER THE CURVE; BIOEQUIVALENCE; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG HALF LIFE; ENCAPSULATION; FEMALE; HUMAN; HUMAN EXPERIMENT; IMMUNOSUPPRESSIVE TREATMENT; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ADULT; CAPSULES; COMPUTER SIMULATION; CONFIDENCE INTERVALS; CONTINENTAL POPULATION GROUPS; CROSS-OVER STUDIES; ETHNIC GROUPS; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; METABOLIC CLEARANCE RATE; RANDOM ALLOCATION; TACROLIMUS; THERAPEUTIC EQUIVALENCY;

EID: 0031859997     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0041-1345(98)00314-5     Document Type: Conference Paper

References (6)

1. Prograf, tacrolimus capsules, tacrolimus injection (for intravenous infusion only), Fujisawa USA, Inc. Product Label
2. Lee JW, Sukovaty RL, Farme RH, et al: Ther Drug Monitoring 19:201, 1997
3. SAS Institute, Inc. SAS/STAT User's Guide. Version 6, Fourth Edition, Volume 1, Gary, NC: SAS Institute 943 p 1989
4. SAS Institute, Inc. SAS/STAT User's Guide. Version 6, Fourth Edition, Volume 2, Cary, NC: SAS Institute 846 p 1989
5. SAS Institute, Inc. SAS Procedures Guide. Version 6, Third Edition, Cary, NC: SAS Institute 705 p 1990
6. FDA Guidance: Statistical procedures for bioequivalence studies using a standard two-treatment crossover design, 1992