Application of the optimal design approach to improve a pretransplant drug dose finding design for ciclosporin

Journal of Clinical Pharmacology

Volumn 52, Issue 3, 2012, Pages 347-360

  Hennig, Stefanie ^a   Nyberg, Joakim ^a   Fanta, Samuel ^a,b   Backman, Janne T ^b   Hoppu, Kalle ^b   Hooker, Andrew C ^a   Karlsson, Mats O ^a  

^a UPPSALA UNIVERSITY   (Sweden)

^b UNIVERSITY OF HELSINKI   (Finland)

Author keywords

Ciclosporin; diagnostics; optimal design; therapeutic drug monitoring

Indexed keywords

CYCLOSPORIN A;

ANALYTICAL PARAMETERS; ARTICLE; DIAGNOSTIC PROCEDURE; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG MONITORING; HUMAN; INFUSION; INTERMETHOD COMPARISON; MEASUREMENT ERROR; METHODOLOGY; OPTIMAL DESIGN APPROACH; PHARMACOLOGICAL PARAMETERS; POPULATION MODEL; PREDICTION; PRETRANSPLANT TEST DOSE; PROCESS OPTIMIZATION; SAMPLING;

ADMINISTRATION, ORAL; BIOLOGICAL AVAILABILITY; CHILD; CYCLOSPORINE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INJECTIONS, INTRAVENOUS; KIDNEY TRANSPLANTATION; MODELS, BIOLOGICAL;

EID: 84860158847     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010397731     Document Type: Article

References (19)

1. Hoppu K, Koskimies O, Holmberg C, Hirvisalo EL. Pharmacokinetically determined cyclosporine dosage in young children. Pediatr Nephrol. 1991 ; 5: 1-4
2. Fanta S, Jonsson S, Backman JT, Karlsson MO, Hoppu K. Developmental pharmacokinetics of ciclosporin-a population pharmacokinetic study in pediatric renal transplant candidates. Br J Clin Pharmacol. 2007 ; 64: 772-784
3. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther. 2007 ; 82: 17-20
4. Dansirikul C, Staatz CE, Duffull SB, Taylor PJ, Lynch SV, Tett SE. Sampling times for monitoring tacrolimus in stable adult liver transplant recipients. Ther Drug Monit. 2004 ; 26: 593-599
5. Mathew BS, Fleming DH, Jeyaseelan V, et al. A limited sampling strategy for tacrolimus in renal transplant patients. Br J Clin Pharmacol. 2008 ; 66: 467-472
6. Langers P, Cremers SC, den Hartigh J, et al. Individualized population pharmacokinetic model with limited sampling for cyclosporine monitoring after liver transplantation in clinical practice. Aliment Pharmacol Ther. 2007 ; 26: 1447-1454
7. Hennig S, Waterhouse TH, Bell SC, et al. A D-optimal designed population pharmacokinetic study of oral itraconazole in adult cystic fibrosis patients. Br J Clin Pharmacol. 2007 ; 63: 438-450
8. Green B, Duffull SB. Prospective evaluation of a D-optimal designed population pharmacokinetic study. J Pharmacokin Pharmacodyn. 2003 ; 30: 145-161
9. Merle Y, Mentre F. Optimal sampling times for Bayesian estimation of the pharmacokinetic parameters of nortriptyline during therapeutic drug monitoring. J Pharmacokinet Biopharm. 1999 ; 27: 85-101
10. Merle Y, Mentre F. Bayesian design criteria: computation, comparison, and application to a pharmacokinetic and a pharmacodynamic model. J Pharmacokinet Biopharm. 1995 ; 23: 101-125
11. Dodds MG, Hooker AC, Vicini P. Robust population pharmacokinetic experiment design. J Pharmacokinet Pharmacodyn. 2005 ; 32: 33-64
12. Atkinson AC, Bogacka B. Compound and other optimal designs for systems of nonlinear differential equations arising in chemical kinetics. Chemometrics Intelligent Lab Syst. 2002 ; 61: 17-33
13. Foracchia M, Hooker A, Vicini P, Ruggeri A. POPED, a software for optimal experiment design in population kinetics. Comput Methods Programs Biomed. 2004 ; 74: 29-46
14. Nyberg J, Karlsson MO, Hooker AC. Simultaneous optimal experimental design on dose and sample times. J Pharmacokinet Pharmacodyn. 2009 ; 36: 125-145
15. Jonsson EN, Karlsson MO, Milligan PA Pharmaco-metrics: The Science of Quantitative Pharmacology. Ette EI Williams PJ, ed. Hoboken, NJ: John Wiley and Sons, Inc, Publications ; 2007: 183-222.
16. Davidian M, Giltinan DM Nonlinear Models for Repeated Measurement Data (Monographs on Statistics and Applied Probability 62). Boca Raton, FL: Chapman and Hall ; 1998 :
17. Wählby U, Jonsson EN, Karlsson MO. Assessment of actual significance levels for covariate effects in NONMEM. J Pharmacokinet Pharmacodyn. 2001 ; 28: 231-252
18. Holford NH. A size standard for pharmacokinetics. Clin Pharmacokinet. 1996 ; 30: 329-332
19. Atkinson AC, Bogacka B. Compound D- and Ds- optimal designs for determining the order of a chemical reaction. Technometrics. 1997 ; 39: 347-356