Modelling a spontaneously reported side effect by use of a Markov mixed-effects model

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 32, Issue 2, 2005, Pages 261-281

  Zingmark, Per Henrik ^a,b   Kågedal, Matts ^a   Karlsson, Mats O ^b  

^a ASTRAZENECA R AND D   (Sweden)

^b UPPSALA UNIVERSITY   (Sweden)

Author keywords

Categorical data; Markov model; Mixed effects models; NONMEM; Side effect pharmacodynamics

Indexed keywords

UNCLASSIFIED DRUG;

ARTICLE; CENTRAL NERVOUS SYSTEM; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL TRIAL; CONCENTRATION (PARAMETERS); CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DATA ANALYSIS; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG EXPOSURE; DRUG FORMULATION; DRUG INFUSION; DRUG TOLERABILITY; EVALUATION; EXPERIMENT; HUMAN; MALE; MARKOV MIXED EFFECTS MODEL; NORMAL HUMAN; PARAMETER; PREDICTION; PRIORITY JOURNAL; PROBABILITY; RANDOMIZED CONTROLLED TRIAL; RECORDING; SCORING SYSTEM; SELF REPORT; SIDE EFFECT; SIMULATION; STATISTICAL MODEL; VOLUNTEER;

EID: 28244452840     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-005-0021-7     Document Type: Article

References (16)

1. L.B. Sheiner 1994 A new approach to the analysis of analgesic drug trials, illustrated with bromfenac data Clin. Pharmacol. Ther. 56 3 309 322
2. P.H. Zingmark C. Edenius M.O. Karlsson 2004 Pharmacokinetic/ Pharmacodynamic models for monoclonal antibody actions on the number of target cells and receptors as measured by FACS Br. J. Clin. Pharmacol. 58 4 378 389
3. P.H. Zingmark M. Ekblom T. Odergren T. Ashwood P. Lyden M.O. Karlsson E.N. Jonsson 2003 Population pharmacokinetics of clomethiazole and its effect on the natural course of sedation in acute stroke patients Br. J. Clin. Pharmacol. 56 173 183
4. C.A.J Knibbe K.P. Zuideveld J. DeJongh P.F.M Kuks L.P.H.J. Aarts M. Danhof 2002 Population pharmacokinetic and pharmacodynamic modelling of propofol for long-term sedation in critically ill patients: A comparison between propofol 6% and propofol 1% Clin. Pharmacol. Ther. 72 670 684
5. P. Girard T.F. Blaschke H. Kastrissios L.B. Sheiner 2002 A Markov mixed effect regression model for drug compliance Stat. Med. 17 2313 2333
6. M.O. Karlsson R.C. Schoemaker B. Kemp A.F. Cohen J.M.A. Van Gerven B. Tuk C.C. Peck M. Danhof 2000 A pharmacodynamic Markov mixed-effects model for the effect of temazepam on sleep Clin. Pharmacol. Ther. 68 2 175 188
7. S.L. Beal L.B. Seiner 1992 NONMEM User Guides University of California San Fransisco, CA NONMEM project group
8. E.N. Jonsson M.O. Karlsson 1999 Xpose-an S-PLUS population pharmacokinetic/pharmacodynamic model building aid for NONMEM Comp Meth. Prog. Med. 58 51 64
9. E.H. Cox C. Veyrat-Follet S.L. Beal E. Fuesau S. Kenkare L.B. Sheiner 2000 A population pharmacokinetic-pharmacodynamic analysis of repeated measures time-to-event pharmacodynamic responses: The antiemetic effect of ondansetron J. Pharmacokinet. Biopharm. 27 6 625 644
10. J.W. Mandema D.R. Stanski 1996 Population pharmacodynamic model for keterolac analgesia Clin. Pharmacol. Ther. 60 6 619 635
11. M.O. Karlsson, Jonsson E.N., and P. H. Zingmark. Models for sedation scores in acute stroke patients. In Measurements and Kinetics of in vivo Drug Effects, Advances in Simultaneous Pharmacokinetic/Pharmacodynamic Modelling, 4th International Symposium, 24-27, April 2002, Noordwijkerhout, The Netherlands, 2002
12. Y. Yano S.L. Beal L.B. Sheiner 2001 Evaluating pharmacokinetic/ pharmacodynamic models using the posterior predictive check J. Pharmacokin Pharmacodyn. 28 2 171 192
13. L.B. Sheiner D.R. Stanski S. Vozeh R.D. Miller J. Ham 1979 Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine Clin Pharmacol. Ther. 25 358 371
14. M. Gårdmark L. Brynne M. Hammarlund-Udenaes M.O. Karlsson 1999 Interchangeability and predicitive performance of empirical tolerance models Clin. Pharmackinet. 36 145 167
15. M.O. Karlsson S.L. Beal L.B. Sheiner 1995 Three new residual error models for population PK/PD analyses J. Pharmacokin. Biopharm 23 6 651 672
16. H.C. Porchet N.L. Benowitz L.B. Sheiner 1988 Pharmacodynamic model of tolerance: application to nicotine J. Pharmacol. Exp. Ther. 244 231 236