Tacrolimus (FK506): Validation of a sensitive enzyme-linked immunosorbent assay kit for and application to a clinical pharmacokinetic study

Therapeutic Drug Monitoring

Volumn 19, Issue 2, 1997, Pages 201-207

  Lee, Jean W ^a   Sukovaty, Richard L ^a   Farmen, Raymond H ^a   Dressier, Dawna E ^b   Alak, Ala ^b   Bekersky, Ihor ^b  

^a Harris Laboratories Inc Lincolnshire   (United States)

^b Fujisawa USA ^*  (United States)

Author keywords

ELISA kit; FK506; Pharmacokinetic studies; Tacrolimus

Indexed keywords

HORSERADISH PEROXIDASE; METHANOL; TACROLIMUS;

ARTICLE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DISTRIBUTION; DRUG HALF LIFE; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; QUALITY CONTROL;

ANIMALS; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; MICE; TACROLIMUS;

EID: 0031455115     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007691-199704000-00015     Document Type: Article

References (19)

1. Kobayashi M, Tamura K, Katayama N, et al. FK 506 assay past and present - characteristics of FK 506 ELISA. Transplant Proc 1991;23:2725-9.
2. Peters DH, Fitton A. Plosker GL, et al. Tacrolimus. A review of its pharmacology, and therapeutic potential in hepatic and renal transplantation. Drugs 1993;46:1-51.
3. Tamura K, Kobayashi M, Hoshimoto K, et al. A highly sensitive method to assay FK 506 levels in plasma. Transplant Proc 1987; 19:23-5.
4. Cadoff EM, Venkataramanan R, Krajack A, et al. Assay of FK 506 in plasma. Transplant Proc 1990;22:50-1.
5. Warty VS, Venkataramanan R, Zendehrouh P, et al. Practical aspects of FK 506 analysis (Pittsburgh experience). Transplant Proc 1991;23:2730-1.
6. D'Ambrosio R, Girzaitis, Jusko WJ. Validation and quality assurance program for monitoring tacrolimus (FK 506) concentrations in plasma and whole blood. Ther Drug Monit 1993;15:414-26.
7. Beyens AJ, Wijnen RMH, Beuman GH, van der Heyden J, Kootstra G, van As H. FK 506: monitoring in plasma or in whole blood? Transplant Proc 1991;23:2745-7.
8. Wallemacq PE, Firdaous I, Hassoun A. Improvement and assessment of enzyme-linked immunosorbent assay to detect low FK506 concentrations in plasma or whole blood within 6 hours. Clin Chem 1993;39:1045-9.
9. Zeevi A, Eiras G, Kaufman C, et al. Correlation between bioassayed plasma levels of FK 506 and lymphocyte growth from liver transplant biopsies with histological evidence of rejection. Transplant Proc 1991;23:1406-8.
10. Murthy JN, Chen Y, Warty VS, et al. Radioreceptor assay for quantifying FK-506 immunosuppressant in whole blood. Clin Chem 1992;38:1307-10.
11. Christians U, Kruse C, Kownatzki R, et al. Measurement of FK 506 by HPLC and isolation and characterization of its metabolites. Transplant Proc 1991;23:940-1.
12. Takada K, Oh-Hashi M, Yoshikawa H, et al. Determination of a novel potent immunosuppressant (FK-506) in rat serum and lymph by high-performance liquid chromatography with chemiluminescence detection. J Chromatogr 1990;530:212-8.
13. Christians U, Braun F, Kosian N, et al. High performance liquid chromatography/mass spectrometry of FK 506 and its metabolites in blood, bile, and urine of liver grafted patients. Transplant Proc 1991;23:2741-4.
14. Christians U, Braun F, Schmidt M, et al. Specific and sensitive measurement of FK 506 and its metabolites in blood, and urine of liver-grafted recipients. Clin Chem 1992;38:2025-32.
15. Venkataramanan R, Jain A, Warty VS, et al. Pharmacokinetics of FK 506 in transplant patients. Transplant Proc 1991;23:2736-40.
16. Winkler M, Ringe B, Baumann J, Loss M, Wonigeit K, Pichlamyr R. Plasma vs whole blood for therapeutic drug monitoring of patients receiving FK 506 for immunosuppression. Clin Chem 1994; 40:2247-53.
17. Tamura K, Fujiimura T, Sakuma S, et al. Interaction of tacrolimus (FK506) and its metabolites with FKBP and calcineurin. Biochem Biophys Res Commun 1994;202:437-43.
18. Grenier FC, Luczkiw J, Bergmann M, et al. A whole blood FK 506 assay for the IMx analyzer. Transplant Proc 1991;23:2748-9.
19. Shah VP, Midha KK, Dighe S, et al. Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci 1992;81:309-12.