Pharmacokinetic based design of individualized dosage regimens using a bayesian approach

Industrial and Engineering Chemistry Research

Volumn 50, Issue 9, 2011, Pages 5114-5130

  Laínez, José Miguel ^a   Blau, Gary ^a   Mockus, Linas ^a   Orçun, Seza ^a   Reklaitis, Gintaras V ^a  

^a PURDUE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BAYESIAN; BAYESIAN APPROACHES; BAYESIAN METHODOLOGY; CLINICAL TRIAL; COMMERCIAL DECISIONS; CONFIDENCE LEVELS; DOSAGE REGIMEN; DRUG CONCENTRATION; DRUG DEVELOPMENT; NEUROPATHIC PAIN; NUMBER OF SAMPLES; PATIENT CARE; PATIENT POPULATION; PATIENT SPECIFIC; PHARMACEUTICAL COMPANY; PHARMACOKINETIC DATA; PHARMACOKINETIC PARAMETERS; PHARMACOKINETIC PROFILES; POPULATION DATA; POSTERIOR DISTRIBUTIONS; PRIOR INFORMATION; REGULATORY AGENCIES; SAMPLING SCHEDULE; SERUM SAMPLES; THERAPEUTIC AGENTS;

BAYESIAN NETWORKS; DRUG DOSAGE; DRUG PRODUCTS; EXPERIMENTS; HEALTH CARE; PHARMACOKINETICS;

POPULATION STATISTICS;

EID: 79955539269     PISSN: 08885885     EISSN: 15205045     Source Type: Journal    
DOI: 10.1021/ie101610r     Document Type: Article

References (42)

1. Rehnquist, J. FDA's Review Process for New Drug Applications: A Management Review; Technical Report OEI-01-01-00590, 2003.
2. Williams, P. J. and Ette, E. I. Pharmacometrics: Impacting Drug Development and Pharmacotherapy. In Pharmacometrics: The Science of Quantitative Pharmacology; Ette, E. I. and Williams, P. J., Eds.; Wiley-Interscience: Hoboken, NJ, 2007; Chapter 1, pp 1 - 21.
3. Eichelbaum, M.; Ingelman-Sundberg, M.; Evans, W. E. Pharmacogenomics and individualized drug therapy Ann. Rev. Med. 2006, 57, 119-137 (Pubitemid 43261982)
4. Krahenbuhl-Melcher, A.; Schlienger, R.; Lampert, M.; Haschke, M.; Drewe, J.; Krahenbuhl, S. Drug-related problems in hospitals-A review of the recent literature Drug Safety 2007, 30, 379-407 (Pubitemid 46740336)
5. Steed, J. Drugged-out Seniors a Prescription for Disaster, Toronto Star, 2008.
6. Boissel, J. P.; Durieu, I.; Girard, P.; Nony, P.; Chauvin, F.; Haugh, M. Dose-Ranging Trials: Guidelines for Data Collection and Standardized Descriptions Controlled Clinical Trials 1995, 16, 319-330
7. Brodie, B. B. Physicochemical and Biochemical Aspects of Pharmacology JAMA, J. Am. Med. Assoc. 1967, 202, 600-609
8. Buxton, I. Pharmacokinetics and Pharmacodynamics: The Dynamics of Drug Absorption, Distribution, Action, and Elimination. In Goodman & Gilman's The Pharmacological Basis of Therapeutics; Brunton, L. L.; Lazo, J. S.; Parker, K. L., Eds.; McGraw-Hill: New York, 2006; Chapter 1.
9. Wagner, J. G. Pharmacokinetics for the Pharmaceutical Scientist; Technomic Publishing Company: Lancaster, PA, 1993.
10. Blau, G.; Lasinski, M.; Orcun, S.; Hsu, S.-H.; Caruthers, J.; Delgass, N.; Venkatasubramanian, V. High fidelity mathematical model building with experimental data: A Bayesian approach Comput. Chem. Eng. 2008, 32, 971-989 (Pubitemid 351199686)
11. Ette, E. I.; Williams, P. J.; Ahmad, A. Population Pharmacokinetic Estimation Methods. In Pharmacometrics: The Science of Quantitative Pharmacology; Ette, E. I.; Williams, P. J., Eds.; Wiley-Interscience: Hoboken, NJ, 2007; Chapter 10, pp 265 - 285.
12. Ette, E. I.; Williams, P. J. Population Pharmacokinetics I: Background, Concepts, and Models Ann. Pharmacother. 2004, 38, 1702-1706 (Pubitemid 39297771)
13. Reilly, P. M.; Blau, G. The use of statistical methods to build mathematical models of chemical reaction systems Can. J. Chem. Eng. 1974, 52, 289-299
14. Ruppert, D.; Cressie, N.; Carroll, R. J. A Transformation/Weighting Model for Estimating Michaelis-Menten Parameters Biometrics 1989, 45, 637-656 (Pubitemid 19165275)
15. Chan, P. L. S.; Weatherley, B.; McFadyen, L. A population pharmacokinetic meta-analysis of maraviroc in healthy volunteers and asymptomatic HIV-infected subjects Br. J. Clin. Pharmacol. 2008, 65, 76-85 (Pubitemid 351366542)
16. Duffull, S. B.; Friberg, L. E.; Dansirikul, C. Bayesian Hierarchical Modeling with Markov Chain Monte Carlo Methods. In Pharmacometrics: The Science of Quantitative Pharmacology; Ette, E. I.; Williams, P. J., Eds.; Wiley-Interscience: Hoboken, NJ, 2007; Chapter 5, pp 137 - 164.
17. FDA, Guidance for Industry: Population Pharmacokinetics; U.S. Department of Health and Human Services: Washington, DC, 1999.
18. Jelliffe, R.; Schumitzky, A.; Guilder, M. V.; Liu, M.; Hu, L.; Maire, P.; Gomis, P.; Barbaut, X.; Tahani, B. 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)
19. Steimer, J.-L.; Mallet, A.; Golmard, J.-L.; Boisvieux, J.-F. Alternative Approaches to Estimation of Population Pharmacokinetic Parameters: Comparison with the Nonlinear Mixed-Effect Model Drug Metab. Rev. 1984, 15, 265-292 (Pubitemid 14123939)
20. Sheiner, L.; Grasela, T. J. Introduction to mixed effect modeling: concepts, definitions, and justification J. Pharmacokinetics and Biopharmaceutics 1991, 19, 11S-24S
21. Mallet, A. A maximum likelihood estimation method for random coefficient regression models Biometrika 1986, 73, 645-656
22. Davidian, M.; Gallant, A. R. Smooth nonparametric maximum likelihood estimation for population pharmacokinetics, with application to Quinidine J. Pharmacokinet. Biopharm. 1992, 20, 529-556 (Pubitemid 23034414)
23. Whiting, B.; Kelman, A. W.; Bryson, S. M.; Derkx, F. H.; Thomson, A. H.; Fotheringham, G. H.; Joel, S. E. Clinical pharmacokinetics: a comprehensive system for therapeutic drug monitoring and prescribing Br. Med.l J. 1984, 288, 541-545 (Pubitemid 14117373)
24. Mehvar, R. Pharmacokinetic-based design and modification of dosage regimens Am. J. Pharm. Educ. 1998, 62, 189-195 (Pubitemid 128655609)
25. Duffull, S. B.; Kirkpatrick, C.; Green, B.; Holford, N. Analysis of population pharmacokinetic data using NONMEM and WinBUGS J. Biopharm. Stat. 2005, 15, 53-73 (Pubitemid 40130000)
26. Salinger, D. H.; McCune, J. S.; Ren, A. G.; Shen, D. D.; Slattery, J. T.; Phillips, B.; McDonald, G. B.; Vicini, P. Real-time Dose Adjustment of Cyclophosphamide in a Preparative Regimen for Hematopoietic Cell Transplant: A Bayesian Pharmacokinetic Approach Clin. Cancer Res. 2006, 12, 4888-4898 (Pubitemid 44338576)
27. McCune, J. S.; Batchelder, A.; Guthrie, K. A.; Witherspoon, R.; Appelbaum, F. R.; Phillips, B.; Vicini, P.; Salinger, D. H.; McDonald, G. B. Personalized Dosing of Cyclophosphamide in the Total Body Irradiation- Cyclophosphamide Conditioning Regimen: A Phase II Trial in Patients With Hematologic Malignancy Clin. Pharm. Ther. 2009, 85, 615-622
28. Bishop, C. M. Pattern Recognition and Machine Learning; Springer Science: New York, NY, 2006.
29. Barrett, J.; Mondick, J.; Narayan, M.; Vijayakumar, K.; Vijayakumar, S. Integration of modeling and simulation into hospital-based decision support systems guiding pediatric pharmacotherapy BMC Med. Inf. Decis. Making 2008, 8, 6
30. Salinger, D. H.; Vicini, P.; Blough, D. K.; O'Donnell, P. V.; Pawlikowski, M. A.; McCune, J. S. Development of a population pharmacokinetics-based sampling schedule to target daily intravenous busulfan for outpatient clinic administration. J. Clin. Pharmacol. 2010, 50, 1292 - 1300.
31. Hsu, S.-H.; Stamatis, S. D.; Caruthers, J. M.; Delgass, W. N.; Venkatasubramanian, V.; Blau, G. E.; Lasinski, M.; Orcun, S. Bayesian Framework for Building Kinetic Models of Catalytic Systems Ind. Eng. Chem. Res. 2009, 48, 4768-4790
32. Metropolis, N.; Rosenbluth, A. W.; Rosenbluth, M. N.; Teller, A. H.; Teller, E. Equation of State Calculations by Fast Computing Machines J. Chem. Phys. 1953, 21, 1087-1092
33. Simonoff, J. S. Smoothing Methods in Statistics; Springer-Verlag: New York, 1996; Springer Series in Statistics.
34. Jeliffe, R.; Schumitzky, D.; Bayard, D.; Leary, R.; Thompson, A.; Boten, A.; Van-Guilder, M.; Bustad, A.; Neely, M. Pharmacokinetic tools to optimize control of drug PK/PD models for best patient care; Technical Report, 2008.
35. Urban, T.; Brown, C.; Castro, R.; Shah, N.; Mercer, R.; Huang, Y.; Brett, C.; Burchard, E.; Giacomini, K. Effects of Genetic Variation in the Novel Organic Cation Transporter, OCTN1, on the Renal Clearance of Gabapentin Clin. Pharmacol. Ther. 2008, 83, 416-421 (Pubitemid 351272627)
36. ARUP-Laboratories, ARUP's Laboratory Test Directory - Gabapentin. http://www.aruplab.com/guides/ug/tests/0090057.jsp (accessed Jan 2011).
37. García, L. L.; Shihabi, Z. K.; Oles, K. Determination of gabapentin in serum by capillary electrophoresis J. Chromatogr., Sect. B 1995, 669, 157-162
38. Neurontin (gabapentin); Technical Report, Parke-Davis: Ann Arbor, MI, 2009.
39. Chow, S.-C.; Liu, J.-P. Design and Analysis of Clinical Trials: Concepts and Methodologies, 2 nd ed.; Wiley Series in Probability and Statistics; Wiley-Interscience: Hoboken, NJ, 2003.
40. R Development Core Team. R: A Language and Environment for Statistical Computing; R Foundation for Statistical Computing: Vienna, Austria, 2008, ISBN 3-900051-07-0.
41. Martin, A. D.; Quinn, K. M.; Park, J. H. Markov chain Monte Carlo (MCMC) Package; Washington University in St. Louis: St. Louis, MO; University of California at Berkeley: Berkeley, CA, 2010.
42. Cosma, I. A.; Evers, L. Markov Chains and Monte Carlo Methods; African Institute for Mathematical Sciences: Cape Town, South Africa; University of Cambridge: Cambridge, U.K.; University of Glasgow: Glasgow, Scotland, 2010.