Pharmacokinetics and bioavailability of mycophenolate mofetil in healthy subjects after single-dose oral and intravenous administration

Journal of Clinical Pharmacology

Volumn 36, Issue 4, 1996, Pages 315-324

  Bullingham, Roy ^a   Monroe, Scot ^a   Nicholls, Andrew ^a   Hale, Michael ^a  

^a Roche Global Development   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; MYCOPHENOLIC ACID BETA D GLUCURONIDE; PRODRUG; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG METABOLISM; ENTEROHEPATIC CIRCULATION; FEMALE; HUMAN; HUMAN EXPERIMENT; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY CLEARANCE; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; RANDOMIZED CONTROLLED TRIAL;

EID: 0029864837     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.1996.tb04207.x     Document Type: Article

References (9)

1. Lee WA, Gu L, Miksztal AR, Chu N, Leung K, Nelson PH: Bioavailability improvement of mycophenolic acid through amino ester derivatization. Pharm Res 1990;7:161-166.
2. European Mycophenolate Mofetil Cooperative Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. Lancet 1995;345:1321-1325.
3. Eugui EM, Almquist S, Muller CD, Allison A: Lymphocyte selective cytostatic and immunosuppressive effects of mycophenolic acid in vitro: role of deoxyguanosine nucleotide depletion. Scand J Immunol 1991;33:161-173.
4. Bullingham RES, Nicholls A, Hale M: Pharmacokinetics of mycophenolate mofetil (RS61443): a short review. Transplant Proc (in press).
5. Tsina I, Kaloostian M, Lee R, Tarnowski T, Wong B: An HPLC method for the determination of mycophenolate mofetil in human plasma. J Chromatogr B Biomed Appl (in press).
6. Tsina I, Chu F, Hama K, Kaloostian M, Tam Y-L, Tarnowski T, Wong B: Manual and automated (robotic) high-performance liquid chromatography methods for the determination of mycophenolic acid and its glucuronide conjugate in human plasma. J Chromatogr B Biomed Appl 1996;675:119-129.
7. Schuirman DJ: A comparison of the two-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15:657-680.
8. Nowak I, Shaw LM: Mycophenolic acid binding to human serum albumin: characterization and relation to pharmacodynamics. Clin Chem 1995;41:1011-1017.
9. Pang KS: Metabolite pharmacokinetics: the area under the curve of metabolite and the fractional rate of metabolism of a drug after different routes of administration for renally and hepatically cleared drugs and metabolites. J Pharmacokinet Biopharm 1981;9: 477-487.