Sparse drug concentration data analysis using a population approach: A valuable tool in clinical pharmacology

Clinical and Experimental Pharmacology and Physiology

Volumn 23, Issue 10-11, 1996, Pages 995-999

  McLachlan, Andrew J ^a  

^a UNIVERSITY OF SYDNEY   (Australia)

Author keywords

Cyclosporin; Fluconazole; Non linear mixed effects modelling; Population pharmacokinetics

Indexed keywords

CYCLOSPORIN A; FLUCONAZOLE;

CLINICAL PHARMACOLOGY; CONFERENCE PAPER; DRUG DEVELOPMENT; HUMAN; INFORMATION PROCESSING; PHARMACODYNAMICS; PHARMACOKINETICS; POPULATION;

EID: 0029810255     PISSN: 03051870     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1440-1681.1996.tb01157.x     Document Type: Conference Paper

References (39)

1. Holford NHG, Peck CC. Population pharmacodynamics and drug development. In: van Boxtel CJ, Holford NHG, Danhof M (eds). The in vivo study of drug action. Eisevier Science, London. 1992; Ch. 21.
2. Ebling WF, Levy G. Population pharmacodynamics: Strategies for concentration- and effect-controlled clinical trials. Ann. Pharmacother. 1996; 30: 12-19.
3. Levy G, Ebling WF, Forrest A. Concentration- or effect-controlled clinical trials with sparse data. Clin. Pharmacol. Ther. 1994; 56: 1-8.
4. Holford NHG. The target concentration approach to clinical drug development. Clin. Pharmacokinet. 1995; 29: 287-91.
5. Whiting B, Kelman AW, Grevel J. Population pharmacokinetics: Theory and clinical application. Clin. Pharmacokinet. 1985; 11: 387-401.
6. Wagner JG. Pharmacokinetics for the pharmaceutical scientist. Technomic Publishing, Lancaster. 1994.
7. Thomson AH, Whiting B. Bayesian parameter estimation and population pharmacokinetics. Clin. Pharmacokinet. 1992; 22: 447-67.
8. Jelliffe RW, Schumitzky A, Van Guilder M et al. Individualizing drug dosage regimens: Role of population pharmacokinetic and dynamic models, Bayesian fitting and adaptive control. Ther. Drug Monit. 1993; 15: 380-93.
9. Peck CC, D'Argenio DZ, Rodman JH. Analysis of pharmacokinetic data for individualizing drug dosage regimens. In: Evans WE, Schentag JJ, Jusko WJ (eds). Applied pharmacokinetics: Principles of therapeutic drug monitoring, 3rd edn., Applied Therapeutics Inc., Vancouver WA. 1992; Ch. 3.
10. Aarons L. Population pharmacokinetics: Theory and practice. Br. J. Clin. Pharmacol. 1991; 32: 669-70.
11. Aarons L. Sparse data analysis. Eur. J. Drug Metab. Pharmacokinet. 1993; 18: 97-100.
12. Sheiner LB, Grasela TH. An introduction to mixed effect modelling: Concepts, definitions and justification. J. Pharmacokinet. Biopharm. 1991; Suppl.: S11-23.
13. Beal SL, Sheiner LB. NONMEM users guide. University of California, San Francisco, 1992.
14. Gomeni R, Pineau G, Mentre F. Population kinetics and conditional assessment of the optimal dosage regimen using the P-PHARM software package. Anticancer Res. 1994; 14: 2321-6.
15. Mallet A, Mentre F, Steimer J-L, Lokiec F. Nonparametric maximum likelihood estimation for population pharmacokinetics, with application to cyclosporin. J. Pharmacokinet. Biopharm. 1988; 16: 311-27.
16. McLachlan AJ, Tett SE. Pharmacokinetics of fluconazole in people with HIV infection: A population analysis. Br. J. Clin. Pharmacol. 1996; 41: 291-8.
17. Tett S, Moore S, Ray J. Pharmacokinetics and bioavailability of fluconazole in two groups of males with HIV infection compared with a group of males without HIV infection. Antimicrob. Agents Chemother. 1995; 39: 1835-41.
18. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
19. Baily GG, Perry FM, Denning DW, Mandal BK. Fluconazole-resistant candidiasis in a HIV cohort. AIDS 1994; 8: 787-92.
20. Collart L, Blaschke TF, Boucher F, Prober CG. Potential of population pharmacokinetics to reduce the frequency of blood sampling required for estimating kinetic parameters in neonates. Dev. Pharmacol. Ther. 1992; 18: 71-80.
21. Lee TC, Charles BG, Steer PA, Flendy VJ, Grant TC. Theophylline population pharmacokinetics from routine monitoring data in very premature infants with apnoea. Br. J. Clin. Pharmacol. 1996; 41: 191-200.
22. Karlsson MO, Thomson AH, McGovern EM, Chow P, Evans TJ, Kelman AW. Population pharmacokinetics of rectal theophylline in neonates. Ther. Drug Monit. 1991; 13: 195-200.
23. Yano I, Tanigawara Y, Yasuhara M et al. Population pharmacokinetics of theophylline. II: Intravenous infusion to patients with stable chronic airway obstruction. Biol. Pharm. Bull. 1993; 16: 501-5.
24. Tod M, Padoin C, Minozzi C, Cougnard J, Petitjean O. Population pharmacokinetic study of isepamicin with intensive care unit patients. Antimicrob. Agents Chemother. 1996; 40: 983-7.
25. Amantea MA, Bowden RA, Forrest A, Working PK, Newman MS, Mamelok RD. Population pharmacokinetics and renal function-sparing effects of amphotericin B colloidal dispersion in patients receiving bone marrow transplants. Antimicrob. Agents Chemother. 1995; 39: 2042-7.
26. Mentre F, Escolono S, Diquet B, Golmard J-L, Mallet A. Clinical pharmacokinetics of zidovudine: Inter- and intraindividual variability and relationship to long term efficacy and toxicity. Eur. J. Clin. Pharmacol. 1993; 45: 397-407.
27. Bauer LA, Horn JR, Pettit H. Mixed-effect modeling for detection and evaluation of drug interactions: Digoxin-quinidine and digoxin-verapamil combinations. Ther. Drug Monit. 1996; 18: 46-52.
28. Grasela TH, Antal EJ, Ereshefsky L, Wells BG, Evans RL, Smith RB. An evaluation of population pharmacokinetics in therapeutic trials. Part II. Detection of a drug-drug interaction. Clin. Pharmacol. Ther. 1987; 42: 433-41.
29. McLachlan AJ, Tett SE. Effect of metabolic inhibitors on cyclosporin-A pharmacokinetics studies using a population approach. Ther. Drug Monit. 1995; 17: 400 (Abstract 67).
30. MacDonald P, Keogh A, Connell J, Harvison A, Richens D, Spratt P. Diltiazem co-administration reduces cyclosporine toxicity after heart transplantation: A prospective randomised study. Transplant Proc. 1992: 24: 2259-62.
31. Keogh A, Spratt P, McCosker C, MacDonald P, Mundy J, Kaan A. Ketoconazole to reduce the need for cyclosporin after cardiac transplantation. N. Engl. J. Med. 1995; 333: 628-33.
32. Back DJ, Tjia JF. Comparative effects of the antimycotic drugs ketoconazole, fluconazole, itraconazole and terbinafine on the metabolism of cyclosporin by human liver microsomes. Br. J. Clin. Pharmacol. 1991; 32: 624-6.
33. Sheiner LB, Benet LZ. Premarketing observational studies of population pharmacokinetics of new drugs. Clin. Pharmacol. Ther. 1985; 38: 481-7.
34. Colburn WA. Controversy IV: Population pharmacokinetics, NONMEM and the pharmacokinetic screen: Academic, Industrial and Regulatory Perspectives. J. Clin. Pharmacol. 1989; 29: 1-6.
35. Tanigawara Y, Nomura H, Kagimoto N, Okumura K, Hori R. Premarketing population pharmacokinetic study of levofloxacin in normal subjects and patients with infectious diseases. Biol. Pharm. Bull. 1995; 18: 315-20.
36. DeVane CL, Grasela TH, Antal EJ, Miller RL. Evaluation of population pharmacokinetics in therapeutic trials. IV. Application to postmarketing surveillance. Clin. Pharmacol. Ther. 1993; 53: 521-8.
37. Vozeh S, Steimer J-L, Rowland M et al. The use of population pharmacokinetics in drug development. Clin. Pharmacokinet. 1996; 30: 81-93.
38. Steimer J-L, Ebelin M-E, Van Bree J. Pharmacokinetic and pharmacodynamic data and models in clinical trials. Eur. J. Drug Metab. Pharmacokinet. 1993; 18: 61-76.
39. Aarons L, Balant LP, Mentre F, Rowland M, Steimer JL, Vozeh S. Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies. Eur. J. Clin. Pharmacol. 1996; 49: 251-4.