Some comments and suggestions concerning population pharmacokinetic modeling, especially of digoxin, and its relation to clinical therapy

Therapeutic Drug Monitoring

Volumn 34, Issue 4, 2012, Pages 368-377

  Jelliffe, Roger W ^a  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

atrial fibrillation; digoxin; optimal individualized drug dosage; population pharmacokinetic dynamic modeling; therapeutic drug monitoring

Indexed keywords

DIGOXIN;

BLOOD SAMPLING; COMPUTER PROGRAM; DISEASE CONTROL; DRUG BLOOD LEVEL; DRUG INDUSTRY; DRUG MONITORING; DRUG TISSUE LEVEL; DRUG TOLERABILITY; EXPERIMENTAL DESIGN; HEART ATRIUM FIBRILLATION; HUMAN; MEASUREMENT ERROR; MODEL; PRIORITY JOURNAL; REVIEW;

DIGOXIN; DRUG MONITORING; HUMANS; MODELS, BIOLOGICAL; SOFTWARE;

EID: 84863820062     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e31825c88bb     Document Type: Review

References (36)

1. Jelliffe R, Gomis P, Schumitzky A. A Population Model of Gentamicin Made With a New Nonparametric Algorithm. Technical Report 90-4. Los Angeles, CA: Laboratory of Applied Pharmacokinetics, USC Keck School of Medicine; 1990.
2. Schumitzky A. Nonparametric EM algorithms for estimating prior distributions. Appl Math Comput. 1991;45:143-157.
3. D'Argenio D. Optimal sampling times for pharmacokinetic experiments. J Pharmacokinet Biopharmaceut. 1981;9:739-756. (Pubitemid 12184821)
4. Reuning R, Sams R, Notari R. Role of pharmacokinetics in drug dosage adjustment. 1. Pharmacologic effects, kinetics, and apparent volume of distribution of digoxin. J Clin Pharmacol. 1973;13:127-141.
5. Beal S, Sheiner L. NONMEM User's Guide. NONMEM Project Group. San Francisco, CA: University of California; 1995.
6. Mallet A. A maximum likelihood estimation method for random coefficient regression models. Biometrika. 1986;73:645-656.
7. Bustad A, Terziivanov D, Leary R, et al. Parametric and nonparametric population methods: their comparative performance in analyzing clinical data set and two Monte Carlo simulation studies. Clin Pharmacokinet. 2006;45:365-383.
8. Premaud A, Weber L, Tonshoff B, et al. Population pharmacokinetics of mycophenolic acid in pediatric renal transplant patients using parametric and nonparametric approaches. Pharmacol Res. 2011;63:216-224.
9. Bertsekas D. Dynamic Programming: Deterministic and Stochastic Models. Englewood Cliffs, NJ: Prentice-Hall; 1987:144-146.
10. Bulitta J, Bingolbali A, Shin B, et al. Development of a new pre- and post- processing tool (SADAPT - TRAN) for nonlinear mixed effect modeling is S-ADAPT. AAPS J. 2011;2:201-2121.
11. Chan P, Jacqmin P, Lavielle M, et al. The use of the SAEM algorithm in MONOLIX software for estimation of population pharmacokinetic - pharmacodynamic - viral dynamics parameters of maraviroc in asymptomatic HIV subjects. J Pharmacokinet Pharmacodyn. 2011;38:41-61.
12. Lindsay B. The geometry of mixture likelihoods: a general theory. Ann Stat. 1983;11:86-94.
13. Savic R, Kjellson, Karlsson M. Evaluation of the nonparametric estimation method in NONMEM VI. Eur J Pharmaceut Sci. 2009;37:27-35.
14. Baverel P. Development and Evaluation of Nonparametric Mixed Effects Models [Ph.D. Dissertation]. Uppsala, Sweden: University of Uppsala; 2011.
15. Leary R, Chittenden J. A nonparametric analogue to POSTHOC estimates for exploratory data analysis. Poster presented at: Population Approach Group Europe Meeting; June 18-20, 2008; Marseille, France.
16. Jelliffe R, Bayard D, Milman M, et al. Achieving target goals most precisely using nonparametric compartmental models and "multiple model" design of dosage regimens. Ther Drug Monit. 2000;22:346-353. (Pubitemid 30346453)
17. Bayard D, Jelliffe R, Schumitzky A, et al. Precision drug dosage regimens using multiple model adaptive control: theory, and application to simulated vancomycin therapy. In: Selected Topics in Mathematical Physics. Professor R. Vasudevan Memorial Volume. Chennai, India: Allied Publishers Ltd; 1995:407-426.
18. Jelliffe R, Bayard D, Schumitzky A, et al. A new clinical software package for multiple model (MM) design of drug dosage regimens for planning, monitoring, and adjusting optimally individualized drug therapy for patients. Presented at: 4th International Meeting on Mathematical Modeling, Technical University of Vienna; February 6, 2003; Vienna, Austria.
19. DeGroot M. Probability and Statistics. 2nd ed. Reading, MA: Addison-Wesley; 1989:420-423.
20. Jelliffe RW, Schumitzky A, Van Guilder M, et al. Individualizing drug dosage regimens: roles of population pharmacokinetic and dynamic models, Bayesian fitting, and adaptive control. Ther Drug Monit. 1993;15:380-393. (Pubitemid 23297240)
21. Neely M. Pmetrics. A software package in R for parametric and non-parametric population modeling and Monte Carlo simulation. Available at: www.lapk.org.
22. Kramer W, Lewis R, Cobb T, et al. Pharmacokinetics of digoxin: comparison of a two and a three compartment model in man. J Pharmacokinet Biopharmaceut. 1974;2:299-312.
23. Sumner D, Russell A. Digoxin pharmacokinetics: multicompartmental analysis and its clinical implications. J Clin Pharmacol. 1976;3:2221-2229.
24. Lisalo E. Clinical pharmacokinetics of digoxin. Clin Pharmacokinet. 1977;2:1-16.
25. Wettrell G. Distribution and elimination of digoxin in infants. Eur J Clin Pharmacol. 1977;11:329-335. (Pubitemid 8123808)
26. Morselli P, Assael B, Gomeni R, et al. Digoxin pharmacokinetics during human development. In: Morselli P, Garattini S, Sereni F, eds. Basic and Therapeutic Aspects of Perinatal Pharmacology. New York, NY: Raven Press; 1975.
27. Weiner P, Bassan M, Jarchovsky J, et al. Clinical course of acute atrial fibrillation treated with rapid digitalization. Am Heart J. 1983;105:223-227. (Pubitemid 13188268)
28. Doherty J. Digitalis glycosides - pharmacokinetics and their clinical implications. Ann Int Med. 1973;79:229-238.
29. Chamberlain D, White R, Howard M, et al. Plasma digoxin concentrations in patients with atrial fibrillation. Br Med J. 1970;3:429-432.
30. Chamberlain D. Plasma digoxin concentrations as a guide to therapeutic requirements. In: Davies D, Prichard B, eds. Biological Effects of Drugs in Relation to their Plasma Concentrations. Baltimore, MD: University Park Press; 1973:135-143.
31. Goldman S, Probst P, Selzer A, et al. Inefficacy of " therapeutic" serum levels of digoxin in controlling the ventricular rate in atrial fibrillation. Am J Cardiol. 1975;35:651-655.
32. Falk R, Knowlton A, Bernard S, et al. Digoxin for converting atrial fibrillation to sinus rhythm. A random double-blinded trial. Ann Int Med. 1987;4:503-506. (Pubitemid 17095032)
33. Jelliffe R. Estimation of creatinine clearance in patients with unstable renal function, without a urine specimen. Am J Nephrol. 2002;22:320-324.
34. The Digitalis in Acute Atrial Fibrillation (DAAF) Trial Group - Intravenous digoxin in acute atrial fibrillation. Results of a randomized, placebo-controlled multicentre trial in 239 patients. Eur Heart J. 1997;18:649-654.
35. Jordaens L, Trouerbach J, Calle P, et al. Conversion of atrial fibrillation to sinus rhythm and rate control by digoxin in comparison to placebo. Eur Heart J. 1997;18:643-648. (Pubitemid 27182359)
36. Hornestam B, Jerling M, Karlsson M, et al. Intravenously administered digoxin in patients with acute atrial fibrillation: a population pharmacokinetic/pharmacodynamic analysis based on the Digitalis on Acute Atrial Fibrillation trial. Eur J Clin Pharmacol. 2003;58:747-755. (Pubitemid 36399231)