Quality assessment issues of new immunosuppressive drugs and experimental experience

Therapeutic Drug Monitoring

Volumn 18, Issue 4, 1996, Pages 362-367

  Holt, David W ^a   Jones, Kirsty ^a   Lee, Terry ^a   Stadler, Petra ^c   Johnston, Atholl ^b  

^a ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^b ST BARTHOLOMEW S HOSPITAL   (United Kingdom)

^c Fujisawa GmbH   (Germany)

Author keywords

Cyclosporine; Immunosuppressive drugs; Mycophenolic acid; Quality assessment programmes; Sirolimus; Tacrolimus

Indexed keywords

CYCLOSPORIN; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; TACROLIMUS;

ANALYTIC METHOD; ANTIBODY SPECIFICITY; CONFERENCE PAPER; DRUG BLOOD LEVEL; DRUG INFORMATION; DRUG MONITORING; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; PRIORITY JOURNAL; QUALITY CONTROL; RISK ASSESSMENT;

CYCLOSPORINE; DRUG MONITORING; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MYCOPHENOLIC ACID; POLYENES; SIROLIMUS; TACROLIMUS;

EID: 0029814124     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007691-199608000-00008     Document Type: Conference Paper

References (40)

1. Holt DW, Marwaha G, Jones K, Johnston A. Quality assurance programs for immunosuppressive drugs: cyclosporine and beyond. Ther Drug Monit 1993;15:472-7.
2. Holt DW, Mueller EA, Kovarik JM, van Bree JB, Kutz K. The pharmacokinetics of Sandimmun Neoral: a new oral formulation of cyclosporine. Transplant Proc 1994;26: 2935-9.
3. Holt DW, Mueller EA, Kovarik JM, van Bree JB, Richard F, Kutz K. Sandimmun Neoral pharmacokinetics: impact of the new oral formulation. Transplant Proc 1995;27:1434-7.
4. Holt DW, Johnston A, Roberts NB, Tredger JM, Trull AK. Methodological and clinical aspects of cyclosporin monitoring. Report of the Association of Clinical Biochemists Task Force. Ann Clin Biochem 1994;31:420-46.
5. Morris RG, Tett SE, Ray JE. Cyclosporin A monitoring in Australia: consensus recommendations. Ther Drug Monit 1994;16:570-6.
6. Sketris I, Yatscoff R, Keown P, et al. Optimizing the use of cyclosporine in renal transplant patients. Clin Biochem 1995;28:195-211.
7. Oellerich M, Armstrong VW, Kahan BD, et al. Lake Louise Consensus Conference on Cyclosporin Monitoring in Organ Transplantation: report of the consensus panel. Ther Drug Monit 1995;17:642-54.
8. Jusko WJ, Thomson AW, Fung J, et al. Consensus document: therapeutic monitoring of tacrolimus (FK-506). Ther Drug Monit 1995;17:606-14.
9. Yatscoff RW, Boeckx R, Holt DW, et al. Consensus guidelines for therapeutic drug monitoring of rapamycin: report of the consensus panel. Ther Drug Monit 1995;17:676-80.
10. Shaw LS, Sollinger HW, Halloran P, et al. Mycophenolate mofetil: a report of the consensus panel. Ther Drug Monit 1995;17:690-9.
11. Büttner J, Borth R, Boutwell JH, Broughton PMG, Bowyer RC. Recommendation on quality control in clinical chemistry, part 2. Assessment of analytical methods for routine use. J Clin Chem Clin Biochem 1980;18:78-88.
12. Johnston A, Holt DW. Concentration-controlled trials: what does the future hold? Clin Pharmacokinet 1995;28:93-9.
13. British Standards Institute. Implementation of ISO 5725-1. Accuracy (trueness and precision) of measurements, methods and results. Part 1. General principles and definitions. London: British Standards Institute, 1994.
14. Holt DW, Johnston A. Cyclosporine A: analytical methodology and factors impacting on TDM. Ther Drug Monit 1995;17:625-30.
15. Gonschior AK, Christians U, Braun F, et al. Measurement of blood concentrations of FK506 (tacrolimus) and its metabolites in seven liver graft patients after the first dose by h.p.l.e.-MS and microparticulate enzyme immunoassay (MEIA). Br J Clin Pharmacol 1994;38:567-71.
16. Takada K, Oh-Hashi M, Yoshikawa H, Muranishi S. Determination of a novel potent immunosuppressant (FK506) in rat serum and lymph by high-performance liquid chromatography with chemiluminescence detection. J Chromatogr 1990;530:212-8.
17. Friob MC, Hassoun A, Latinne D, Lhoëst G, Otte JB, Wallemacq PE. A combined HPLC-ELISA evaluation of FK 506 in transplant patients. Transplant Proc. 1991;23:2750-2.
18. Wallemacq PE, Reding R. FK506 (tacrolimus), a novel immunosuppressant in organ transplantation: clinical, biomédical and analytical aspects. Clin Chem 1993;39:2219-28.
19. Winkler M, Christians U, Stoll K, Baumann J, Pilchmayr R. Comparison of different assays for the quantitation of FK 506 levels in blood or plasma. Ther Drug Monit 1994;16:281-6.
20. Winkler M, Ringe B, Baumann J, Loss M, Wonigeit K, Pilchmayr R. Plasma vs whole blood for therapeutic drug monitoring of patients receiving FK 506 for immunosuppression. Clin Chem 1994;40:2247-53.
21. D'Ambrosio R, Girzaitis N, Jusko W. Multicenter comparison of tacrolimus (FK 506) whole blood concentrations as measured by the Abbott IMx analyzer and enzyme immunoassay with methylene chloride extraction. Ther Drug Monit 1994;16:287-92.
22. Annesley T, Hunter B, Fidler D, Giachero D. Stability of tacrolimus (FK 506) and cyclosporin G in whole blood. Ther Drug Monit 1995;17:361-5.
23. Freeman D, Stawecki M, Howson B. Stability of FK 506 in whole blood samples. Ther Drug Monit 1995;17:266-77.
24. D'Ambrosio R, Girzaitis N, Jusko W. Validation and quality assurance program for monitoring tacrolimus (FK506) concentrations in plasma and whole blood. Ther Drug Monit 1993;15:414-26.
25. Yatscoff RW, LeGatt DF, Keenan R, Chackowsky P. Blood distribution of rapamycin. Transplantation 1993;56:1202-6.
26. Napoli KM, Kahan BD. Sample clean-up and high-performance liquid Chromatographic techniques for measurement of whole blood rapamycin concentrations. J Chromatogr 1994;654:111-20.
27. Sewing KF, Streit F, Schiebel HM, et al. Sensitive and specific quantification of sirolimus (rapamycin) and its metabolites in blood and urine of kidney graft recipients using HPLC/ electro-spray-mass spectrometry (LC/ES/MS) [Abstract]. Ther Drug Monit 1995;17:431.
28. Langman L, LeGatt D, Yatscoff R. Blood distribution of mycophenolic acid. Ther Drug Monit 1994;16:602-7.
29. Sugioka N, Odani H, Ohta T, et al. Determination of a new immunosuppressant, mycophenolate mofetil, and its active metabolite, mycophenolic acid, in rat and human body fluids by high-performance liquid chromatography. J Chromatogr 1994;654:249-56.
30. Hayley CJ, Jaklitsch A, McGovan B, et al. Feasibility of an EMIT assay for mycophenolic acid in plasma [Abstract]. Ther Drug Monit 1995;17:431.
31. Nowak I, Shaw LM. Mycophenolic binding to human serum albumin: characterization and relation to pharmacodynamics. Clin Chem 1995;41:1011-7.
32. Lyon AW, Duran G, Raisys VA. Determination of thalidomide by high performance liquid chromatography: methodological strategy for clinical trials. Clin Biochem 1995;28: 467-70.
33. Huupponen R, Pyykko K. Stability of thalidomide in human plasma. Clin Chem 1995;41:1199.
34. Yatscoff RW, Chackowsky P. Quality assurance program for cyclosporin G (OG37-325). Ther Drug Monit 1995;17:342-7.
35. Arteaga C, Brown TD, Kuhan JG, et al. Phase I clinical and pharmacokinetic trial of brequinar sodium (DUP 785; NSC 368390). Cancer Res 1989;49:4648-53.
36. Lucien J, Dias VC, LeGatt DF, et al. The blood distribution and single dose pharmacokinetics of the immunosuppressant leflunomide [Abstract]. Ther Drug Monit 1995;17:402.
37. Dias VC, Lucien J, LeGatt D, Yatscoff RW. Measurement of the active leflunomide metabolite (A77 1726) by reversephase high-performance liquid chromatography. Ther Drug Monit 1995;17:84-8.
38. Albrecht W, Guserle R, Martin W. Drug monitoring of mizoribine in renal transplant patients receiving an immunosuppres-sive triple therapy [Abstract]. Ther Drug Monit 1995;17:402.
39. Havlin KA, Kuhn JG, Koeller J, et al. Deoxyspurgualin: phase I clinical immunological and pharmacokinetic study. Anticancer Drugs 1995;6:229-36.
40. Bullock DG, Libeer JC, Zender R. Minimal requirements for external quality assessment scheme for clinical laboratories in Europe. EQA News 1994;5:1-2.