Model-based drug development: The road to quantitative pharmacology

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 33, Issue 3, 2006, Pages 369-393

  Zhang, Liping ^b   Sinha, Vikram ^a   Forgue, S Thomas ^a   Callies, Sophie ^a   Ni, Lan ^a   Peck, Richard ^a   Allerheiligen, Sandra R B ^a  

^a ELI LILLY AND COMPANY   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

Decision making; Disease model; Drug exposure response model; Gemcitabine; Knowledge management; Model based drug development; Quantitative pharmacology; Raloxifene

Indexed keywords

ARTICLE; DECISION MAKING; DISEASE MODEL; DRUG EXPOSURE; DRUG INDUSTRY; DRUG RESPONSE; FOOD AND DRUG ADMINISTRATION; MATHEMATICAL MODEL; PRIORITY JOURNAL; STATISTICAL MODEL; VALIDATION STUDY;

ADULT; AGED; ALGORITHMS; ANTIMETABOLITES, ANTINEOPLASTIC; BIOLOGICAL MARKERS; CLINICAL TRIALS; COMPUTER SIMULATION; DECISION MAKING; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INDUSTRY; FEMALE; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; OSTEOCALCIN; OSTEOPOROSIS, POSTMENOPAUSAL; PHARMACOLOGY; RALOXIFENE; SELECTIVE ESTROGEN RECEPTOR MODULATORS; TREATMENT OUTCOME;

EID: 33745779940     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-006-9010-8     Document Type: Article

References (52)

1. US. Food and Drug Administration. Challenge and opportunity on the critical path to new medical products. http://www.fda.gov/oc/initiatives/ criticalpath/whitepaper.html (2004).
2. J. V. Gobburu, and P. J. Marroum. Utilization of pharmacokinetic- pharmacodynamic modelling and simulation in regulatory decision-making. Clin. Pharmacokinet. 40:883-892 (2001).
3. L. B. Sheiner and J. L. Steimer. Pharmacokinetic/pharmacodynamic modeling in drug development. Ann. Rev. Pharmacol. Toxicol. 40:67-95 (2000).
4. C. F. Burman, B. Hamrén, and P. Olsson. Modelling and simulation to improve decision-making in clinical development. Pharm. Stat. 4:47-58 (2005).
5. B. Meibohm and H. Derendorf. Pharmacokinetic/Pharmacodynamic studies in drug development. J. Pharm. Sci. 91:18-31 (2002).
6. C. Minto and T. Schnider. Expanding clinical applications of population pharmacodynamic modelling. Br. J. Clin. Pharmacol. 46:321-333 (1998).
7. L. J. Lesko, M. Rowland, C. C. Peck, and T. F. Blaschke. Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans. Pharm. Res. 17:1335-1344 (2000).
8. C. C. Peck, W. H. Barr, L. Z. Benet, J. Collins, R. E. Desjardins, D. E. Furst, J. G., Harter, G. Levy, T. Ludden, and J. H. Rodman. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. J. Clin. Pharmacol. 34:111-119 (1994).
9. L. P. Balant and M. Gex-Fabry. Modelling during drug development. Eur. J. Pharm. Biopharm. 50:13-26 (2000).
10. D. Noble, K. Levin, and W. Scott. Biological simulations in drug discovery. Drug Discov. Today 4:10-16 (1999).
11. D. R. Stanski. Model-based drug development: a critical path opportunity. http://www.fda.gov/oc/initiatives/criticalpath/stanski/stanski.html (2004).
12. P. Chaikin, G. R. Rhodes, R. Bruno, S. Rohatagi, and C. Natarajan. Pharmacokinetics/pharmacodynamics in drug development: an industrial perspective. J. Clin. Pharmacol. 40:1428-1438 (2000).
13. J. W. Mandema, D. Hermann, W. Wang, T. Sheiner, M. Milad, R. Bakker-Arkewa, and D. Hartman. Model-based development of gemcabene, a new lipid altering agent. The AAPS Journal 7:E513-E522 (2005).
14. K. S. Blesch, R. Gieschke, Y. Tsukamoto, B. G. Reigner, H. U. Burger, and J. L. Steimer. Clinical pharmacokinetic/pharmacodynamic and physiologically based pharmacokinetic modeling in new drug development: the capecitabine experience. Invest. New Drugs 21:195-223 (2003).
15. M. O. Karlsson, T. Anehall, L. E. Friberg, A. Henningsson, C. Kloft, M. Sandstrom, and R. Xie. Pharmacokinetic/pharmacodynamic modelling in oncological drug development. Basic Clin. Pharmacol. Toxicol. 96:206-211 (2005).
16. J. C. Panetta, L. C. Iacono, P. C. Adamson, and C. F. Stewart. The importance of pharmacokinetic limited sampling models for childhood cancer drug development. Clin. Cancer Res. 9:5068-5077 (2003).
17. D. Andes. Pharmacokinetics and pharmacodynamics in the development of antifungal compounds. Curr. Opin. Investig. Drugs 4:991-998 (2003).
18. F. P. Theil, T. W. Guentert, S. Haddad, and P. Poulin. Utility of physiologically based pharmacokinetic models to drug development and rational drug discovery candidate selection. Toxicol. Lett. 18:29-49 (2003).
19. A. K. Saha, J. Mazumdar, and S. S. Kohles. Prediction of growth factor effects on engineered cartilage composition using deterministic and stochastic modeling. Ann. Biomed. Eng. 32:871-879, (2004).
20. A. Bangs. Predictive biosimulation and virtual patients in pharmaceutical R and D. Stud. Health. Technol. Inform. 111:37-42 (2005).
21. N. Parrott, H. Jones, N. Paquereau, and T. Lave. Application of full physiological models for pharmaceutical drug candidate selection and extrapolation of pharmacokinetics to man. Basic Clin. Pharmacol. Toxicol. 96:193-199 (2005).
22. L. B. Sheiner. Learning vs. confirming in clinical drug development. Clin. Pharmacol. Ther. 61:275-291 (1997).
23. P. Vicini, M. R. Gastonguay, and D. M. Foster. Model-based approaches to biomarker discovery and evaluation: a multidisciplinary integrated review. Crit. Rev. Biomed. Eng. 30:379-418 (2002).
24. N. H. G. Holford, M. Hale, H. C. Ko, J.-L. Steimer, L. B. Sheiner, C. C. Peck. Contributors: P. Bonate, W. R. Gillespie, T. Ludden, D. B. Rubin, D. Stanski (eds). Simulation in drug development: good practice. http://cdds.ucsf.edu/research/sddgpreport.php. (1999).
25. H. C. Kimko, and S. B. Duffell. Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective. Drugs and the Pharmaceutical Sciences, Vol. 127, Marcel Dekker, New York, 2002.
26. A. Pozniak and M. R. Nelson. Against the proposition: all patients with advanced HIV disease should be offered rifabutin prophylaxis. Genitourin. Med. 72:269-271 (1996).
27. T. M. Post, J. I. Freijer, J. de Jongh, and M. Danhof. Disease system analysis: basic disease progression models in degenerative disease. Pharm. Res. 22:1038-1049 (2005).
28. C. Minto and T. Schnider. Expanding clinical applications of population pharmacodynamic modelling. Br. J. Clin. Pharmacol. 46(3):21-333 (1998).
29. S. Allerheiligen. Quantitative pharmacology: utilizing PK/PD in drug discovery and development. Population Approach Group in Europe 14th Annual Meeting, Pamplona, Spain (2005).
30. J. Y. Chien, S. Friedrich, M. A. Heathman, D. P. de Alwis, and V. Sinha. Pharmacokinetics/pharmacodynamics and the stages of drug development: role of modeling and simulation Pharm Res, in press.
31. P. L. Zinzani, G. Baliva, M. Magagnoli, M. Bendandi, G. Modugno, F. Gherlinzoni, G. F. Orcioni, S. Ascani, R. Simoni, S. A. Pileri, and S. Tura. Gemcitabine treatment in pretreated cutaneous T-cell lymphoma: experience in 44 patients. J. Clin. Oncol. 18:2603-2606 (2000).
32. R. Grunewald, H. Kantarjian, M. Du, K. Faucher, P. Tarassoff, and W. Plunkett. Gemcitabine in leukemia: a phase I clinical, plasma, and cellular pharmacology study. J. Clin. Oncol. 10:406-413 (1992).
33. US. Food and Drug Administration Oncology Tools Product Label Details for Prescribing gemcitabine http://www.accessdata.fda.gov/scripts/cder/onctools/ prescribe.cfm?GN=gemcitabine. (1998).
34. F. Eckel, R. Schmelz, J. Erdmann, M. Mayr, and C. Lersch. Phase II trial of a 24-hour infusion of gemcitabine in previously untreated patients with advanced pancreatic adenocarcinoma. Cancer Invest. 21:690-694 (2003).
35. S. L. Beal and L. B. Sheiner. NONMEM Users Guides. Globomax Inc., Maryland, 1989-1998.
36. U. Wahlby, E. N. Jonsson, and M. O. Karlsson. Comparison of stepwise covariate model building strategies in population pharmacokinetic- pharmacodynamic analysis. AAPS Pharm. Sci. 4:E27 (2002).
37. B. C. Kuenen, L. Rosen, E. F. Smit, M. R. Parson, M. Levi, R. Ruijter, H. Huisman, M. A. Kedde, P. Noordhuis, W. J. van der Vijgh, G. J. Peters, G. F. Cropp, P. Scigalla, K. Hoekman, H. M. Pinedo, and G. Giaccone. Dose-finding and pharmacokinetic study of cisplatin, gemcitabine, and SU5416 in patients with solid tumors. J. Clin. Oncol. 20:1657-1667 (2002).
38. V. Gandhi, W. Plunkett, M. Du, M. Ayres, and E. H. Estey. Prolonged infusion of gemcitabine: clinical and pharmacodynamic studies during a phase I trial in relapsed acute myelogenous leukemia. J. Clin. Oncol. 20:665-673 (2002).
39. R. Grunewald, J. L. Abbruzzese, P. Tarassoff, and W. Plunkett. Saturation of 2′,2′-difluorodeoxycytidine 5′-triphosphate accumulation by mononuclear cells during a phase I trial of gemcitabine. Cancer Chemother. Pharmacol. 27:258-262 (1991).
40. C. J. van Moorsel, J. R. Kroep, H. M. Pinedo, G. Veerman, D. A. Voorn, P. E. Postmus, J. B. Vermorken, C. J. van Groeningen, W. J. van der Vijgh, and G. J. Peters. Pharmacokinetic schedule finding study of the combination of gemcitabine and cisplatin in patients with solid tumors. Ann. Oncol. 10:441-448 (1999).
41. M. Heathman and S. Allerheiligen. Visualization case study: population pharmacokinetics of clinical trial data. In Visualization: Using computer graphics to explore data and present information, Wiley, New York, 1995, pp. 155-158.
42. E. N. Jonsson and M. O. Karlsson. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput. Methods Programs Biomed 58:51-64 (1999).
43. P. D. Delmas, K. E. Ensrud, J. D. Adachi, K. D. Harper, S. Sarkar, C. Gennari, J. Y. Reginster, H. A. Pols, R. R. Recker, S. T. Harris, W. Wu, H. K. Genant, D. M. Black, and R. Eastell. Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial. J. Clin. Endocrinol. Metab. 87:3609-3617 (2002).
44. S. Sarkar, B. H. Mitlak, M. Wong, J. L. Stock, D. M. Black, and K. D. Harper. Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner. Res. 17:1-10 (2002).
45. N. H. Bjarnason, S. Sarkar, T. Duong, B. Mitlak, P. D. Delmas, and C. Christiansen. Six and twelve month changes in bone turnover are related to reduction in vertebral fracture risk during 3 years of raloxifene treatment in postmenopausal osteoporosis. Osteoporos. Int. 12:922-930 (2001).
46. P. L. S. Chan and N. H. G. Holford. Drug Treatment effects on disease progression. Ann. Rev. Pharmacol. Tox. 41:625-659 (2001).
47. C. de Boor. A Practical Guide to Splines. Springer, New York, 1978.
48. W. J. Jusko and H. C. Ko. Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin. Pharmacol. Ther. 56:406-419 (1994).
49. W. Krzyzanski and W. J. Jusko. Mathematical formalism and characteristics of four basic models of indirect pharmacodynamic responses for drug infusions. J. Pharmacokinet. Biopharm. 26:385-408 (1998).
50. N. H. G. Holford, D. H. Mould, and C. Peck. Disease progress models In Principles of Clinical Pharmacology, A. J. Atkinson, et al. (ed), Academic Press, San Diego, 2001.
51. Y. Yano, S. L. Beal, and L. B. Sheiner. Evaluating pharmacokinetic/ pharmacodynamic models using the posterior predictive check. J. Pharmacokinet. Pharmacodyn 28:171-192 (2001).
52. AAMC and US. Food and Drug Administration. Drug Development Science: Obstacles and Opportunities for Collaboration Among Academia, Industry and Government. https://services.aamc.org/Publications/index.cfm?fuseaction=Product. displayForm& prd_id=135&prv_id=157. (2005).