Estimation of dosing strategies aiming at maximizing utility or responder probability, using oxybutynin as an example drug

European Journal of Pharmaceutical Sciences

Volumn 25, Issue 1, 2005, Pages 123-132

  Jönsson, Siv ^a   Karlsson, Mats O ^a  

^a UPPSALA UNIVERSITY   (Sweden)

Author keywords

Dosing strategy; Individualization; NONMEM; Optimization; Risk benefit; Utility and responder definition

Indexed keywords

OXYBUTYNIN;

ARTICLE; DISEASE SEVERITY; DRUG DETERMINATION; DRUG EFFECT; DRUG MEGADOSE; DRUG SAFETY; DRUG TARGETING; DRUG USE; EXPECTATION; HUMAN; LOW DRUG DOSE; MEDICAL ILLUSTRATION; PARTICLE SIZE; POPULATION MODEL; PREDICTION; PRIORITY JOURNAL; PROBABILITY; PUBLICATION; RISK ASSESSMENT; URGE INCONTINENCE; XEROSTOMIA;

EID: 18044362941     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2005.02.004     Document Type: Article

References (31)

1. A. Agresti Categorical Data Analysis 2002 John Wiley & Sons Hoboken
2. R.U. Anderson, D. Mobley, B. Blank, D. Saltzstein, J. Susset, J.S. Brown for the OROS Oxybutynin Study Group Once daily controlled versus immediate release oxybutynin chloride for urge urinary incontinence J. Urol. 161 1999 1809 1812
3. S.L. Beal, and L.B. Sheiner NONMEM Users Guides (I-VIII) 1989-1998 GloboMax Hanover, MD
4. Biomarkers Definitions Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework Clin. Pharmacol. Ther. 69 2001 89 95
5. W.A. Colburn Biomarkers in drug discovery and development: from target identification through drug marketing J. Clin. Pharmacol. 43 2003 329 341
6. CPMP/EWP/18/01 Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Urinary Incontinence, 2002. Available: http://www.emea.eu.int/pdfs/human/ewp/001801en.pdf (accessed 9 February 2004).
7. J. Cross, H. Lee, A. Westelinck, J. Nelson, C. Grudzinskas, and C. Peck Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999 Pharmacoepidemiol. Drug Saf. 11 2002 439 446
8. H. Derendorf, L.J. Lesko, P. Chaikin, W.A. Colburn, P. Lee, R. Miller, R. Powell, G. Rhodes, D. Stanski, and J. Venitz Pharmacokinetic/pharmacodynamic modeling in drug research and development J. Clin. Pharmacol. 40 2000 1399 1418
9. H. Derendorf, and B. Meibohm Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives Pharm. Res. 16 1999 176 185
10. A.C. Diokno, R.A. Appell, P.K. Sand, R.R. Dmochowski, B.M. Gburek, I.W. Klimberg, and S.H. Kell Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial Mayo Clin. Proc. 78 2003 687 695
11. S. Eriksen, and L.R. Keller A multiattribute-utility-function approach to weighing the risks and benefits of pharmaceutical agents Med. Decis. Making 13 1993 118 125
12. FASS: Läkemedel i Sverige: förteckning över humanläkemedel, 2003. Läkemedelsinformation (LINFO), Stockholm.
13. D.T. Felson, J.J. Anderson, M. Boers, C. Bombardier, D. Furst, C. Goldsmith, L.M. Katz, R. Lightfoot Jr., H. Paulus, and V. Strand American college of rheumatology preliminary definition of improvement in rheumatoid arthritis Arthritis Rheum. 38 1995 727 735
14. J.V. Gobburu, and P.J. Marroum Utilisation of pharmacokinetics- pharmacodynamic modelling and simulation in regulatory decision-making Clin. Pharmacokinet. 40 2001 883 892
15. G. Graham, S. Gupta, and L. Aarons Determination of an optimal dosage regimen using a Bayesian decision analysis of efficacy and adverse effect data J. Pharmacokinet. Pharmacodyn. 29 2002 67 88
16. S.K. Gupta, G. Sathyan, E.A. Lindemulder, P.L. Ho, L.B. Sheiner, and L. Aarons Quantitative characterization of therapeutic index: application of mixed-effects modeling to evaluate oxybutynin dose-efficacy and dose-side effect relationships Clin. Pharmacol. Ther. 65 1999 672 684
17. J.G. Hardman L.E. Limbird P.B. Molinoff R.W. Ruddon A. Goodman Gilman Goodman & Gilman's the Pharmacological Basis of Therapeutics 1996 McGraw-Hill New York
18. E.R. Heerdink, J. Urquhart, and H.G. Leufkens Changes in prescribed drug doses after market introduction Pharmacoepidemiol. Drug Saf. 11 2002 447 453
19. Jönsson, S., Karlsson, M.O., 2001. Factors influencing the choice of individualised dosing strategies based on plasma concentration, therapeutic effect or utility. Population Approach Group in Europe, 10th Meeting, Basel, Switzerland. Available from: http://www.page-meeting.org/default.asp.
20. S. Jönsson, and M.O. Karlsson A rational approach for selection of optimal covariate-based dosing strategies Clin. Pharmacol. Ther. 73 2003 7 19
21. Z. Kirkali, and R.H. Whitaker The use of oxybutynin in urological practice Int. Urol. Nephrol. 19 1987 385 391
22. L.J. Lesko, and A.J. Atkinson Jr. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies Annu. Rev. Pharmacol. Toxicol. 41 2001 347 366
23. C. Minto, and T. Schnider Expanding clinical applications of population pharmacodynamic modelling Br. J. Clin. Pharmacol. 46 1998 321 333
24. Product Monograph Ditropan XL, 2003. Available: http://www.janssen-ortho. com/JOI/pdf_files/Ditropan_E.pdf (accessed 29 January 2004).
25. P. Rolan The contribution of clinical pharmacology surrogates and models to drug development - a critical appraisal Br. J. Clin. Pharmacol. 44 1997 219 225
26. P. Rolan, A.J. Atkinson Jr., and L.J. Lesko Use of biomarkers from drug discovery through clinical practice: report of the Ninth European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development Clin Pharmacol Ther 73 2003 284 291
27. L.B. Sheiner PK/PD approach to dose selection A. Breckenridge Optimal dose identification. Proceedings of the Esteve Foundation Symposium IX Lloret de Mar (Girona), Spain, 4-7 October 2000 2001 Excerpta Medica Amsterdam, London 67 78
28. L.B. Sheiner, and S.L. Beal Some suggestions for measuring predictive performance J. Pharmacokinet. Biopharm. 9 1981 503 512
29. L.B. Sheiner, and K.L. Melmon The utility function of antihypertensive therapy Ann. N. Y. Acad. Sci. 304 1978 112 127
30. L.B. Sheiner, and J.L. Steimer Pharmacokinetic/pharmacodynamic modeling in drug development Annu. Rev. Pharmacol. Toxicol. 40 2000 67 95
31. Y.E. Yarker, K.L. Goa, and A. Fitton Oxybutynin. A review of its pharmacodynamic and pharmacokinetic properties, and its therapeutic use in detrusor instability Drugs Aging 6 1995 243 262