357
Views
26
CrossRef citations to date
0
Altmetric
Reviews

The current role of model-based drug development

, PhD, , PhD, , MD & , PhD FCP
Pages 311-321 | Published online: 29 Mar 2010

Bibliography

  • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev 2004;3(8):711-15
  • Frantz S. Pipeline problems are increasing the urge to merge. Nat Rev 2006;5(12):977-9
  • European Medicines Agency. The European Medicines Agency Road Map to 2010: preparing the ground for the future. London; 2005
  • US Food and Drug Administration. Innovation/stagnation: challenge and opportunity on the critical path to new medical products. Rockville, MD; 2004
  • Csajka C, Verotta D. Pharmacokinetic-pharmacodynamic modelling: history and perspectives. J Pharmacokinet Pharmacodyn 2006;33(3):227-9
  • Breimer DD, Danhof M. Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The “wooden shoe” paradigm. Clin Pharmacokinet 1997;32(4):259-67
  • Meibohm B, Derendorf H. Pharmacokinetic/pharmacodynamic studies in drug product development. J Pharm Sci 2002;91(1):18-31
  • Peck CC, Barr BW, Benet LZ, Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Pharm Res 1992;9(6):826-33
  • Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997;61(3):275-91
  • Krishna R. Quantitative clinical pharmacology: making paradigm shifts a reality. J Clin Pharmacol 2006;46(9):966-7
  • Perelson AS. Viral kinetics and mathematical models. Am J Med 1999;107(6B):49S-52S
  • Pfister M, Martin NE, Haskell LP, Barrett JS. Optimizing dose selection with modeling and simulation: application to the vasopeptidase inhibitor M100240. J Clin Pharmacol 2004;44(6):621-31
  • Garcia-Mora B, Santamaria C, Rubio G, Pontones J. Modeling the recurrence-progression process in bladder carcinoma. Comput Math Appl 2008;53:619-30
  • Holford NH, Kimko HC, Monteleone JP, Peck CC. Simulation of clinical trials. Ann Rev Pharmacol Toxicol 2000;40:209-34
  • Eriksen S, Keller LR. A multiattribute-utility-function approach to weighing the risks and benefits of pharmaceutical agents. Med Decis Making 1993;13(2):118-25
  • Zhang L, Sinha V, Forgue ST, Model-based drug development: the road to quantitative pharmacology. J Pharmacokinet Pharmacodyn2006;33(3):369-93
  • Bhattaram VA, Booth BP, Ramchandani RP, Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J 2005;7(3):E503-12
  • Zhang L, Pfister M, Meibohm B. Concepts and challenges in quantitative pharmacology and model-based drug development. AAPS J 2008;10(4):552-9
  • Gobburu JV, Lesko LJ. Quantitative disease, drug, and trial models. Ann Rev Pharmacol Toxicol 2009;49:291-301
  • Lalonde RL, Kowalski KG, Hutmacher MM, Model-based drug development. Clin Pharmacol Ther 2007;82(1):21-32
  • Miller R, Ewy W, Corrigan BW, How modeling and simulation have enhanced decision making in new drug development. J Pharmacokinet Pharmacodyn 2005;32(2):185-97
  • Grasela TH, Fiedler-Kelly J, Walawander CA, Challenges in the transition to model-based development. AAPS J 2005;7(2):488-95
  • Gabrielsson J, Dolgos H, Gillberg PG, Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: strategic considerations. Drug Discov Today 2009;14(7-8):358-72
  • Bhattaram VA, Siddiqui O, Kapcala LP, Gobburu JV. Endpoints and analyses to discern disease-modifying drug effects in early Parkinson's disease. AAPS J 2009;11(3):456-64
  • Krishna R, Schaefer HG, Bjerrum OJ. Effective integration of systems biology, biomarkers, biosimulation and modelling in streamlining drug development. Eur J Pharm Sci 2007;31(1):62-7
  • Venitz J. Using exposure-response and biomarkers to streamline early drug development. Ernst Schering Res Found Workshop 2007;59(1):47-63
  • Bhattaram VA, Bonapace C, Chilukuri DM, Impact of pharmacometric reviews on new drug approval and labeling decisions–a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther 2007;81(2):213-21
  • Levy G. Mechanism-based pharmacodynamic modeling. Clin Pharmacol Ther 1994;56(4):356-8
  • Sheiner LB, Steimer JL. Pharmacokinetic/pharmacodynamic modeling in drug development. Ann Rev Pharmacol Toxicol 2000;40:67-95
  • Bies R, Ko HC, Gobburu J, Effective incorporation of preclinical information into the decision making process for new drug development: an anonymous case study. Clin Pharmacol Ther 2000;67(2):107
  • Chien JY, Friedrich S, Heathman MA, Pharmacokinetics/pharmacodynamics and the stages of drug development: role of modeling and simulation. AAPS J 2005;7(3):544-59
  • Putnam WS, Li J, Haggstrom J, Use of quantitative pharmacology in the development of HAE1, a high-affinity anti-IgE monoclonal antibody. AAPS J 2008;10(2):425-30
  • Chan PL, Holford NH. Drug treatment effects on disease progression. Ann Rev Pharmacol Toxicol 2001;41:625-59
  • Gobburu J. Disease models. Clin Adv Hematol Oncol 2008;6(4):241-2
  • Ploeger BA, Holford NH. Washout and delayed start designs for identifying disease modifying effects in slowly progressive diseases using disease progression analysis. Pharm Stat 2009;8(3):225-38
  • Gupta P, Friberg LE, Karlsson MO, A semi-mechanistic model of CP-690,550-induced reduction in neutrophil counts in patients with rheumatoid arthritis. J Clin Pharmacol 2009. [Epub ahead of print]
  • Hale MD GW, Gupta SK, Tuk B, Holford NH. Clinical trial simulation: streamlining your drug development process. Appl Clin Trials 1996;5:35-40
  • Jumbe N, Yao B, Rovetti R, Clinical trial simulation of a 200-microg fixed dose of darbepoetin alfa in chemotherapy-induced anemia. Oncology (Williston Park) 2002;16(10 Suppl 11):37-44
  • Thames WA, Smith SL, Scheifele AC, Evaluation of the US Oncology Network's recommended guidelines for therapeutic substitution with darbepoetin alfa 200 microg every 2 weeks in both naive patients and patients switched from epoetin alfa. Pharmacotherapy 2004;24(3):313-23
  • Lockwood P, Ewy W, Hermann D, Holford N. Application of clinical trial simulation to compare proof-of-concept study designs for drugs with a slow onset of effect; an example in Alzheimer's disease. Pharm Res 2006;23(9):2050-9
  • Poland B, Wada R. Combining drug-disease and economic modelling to inform drug development decisions. Drug Discov Today 2001;6(22):1165-70
  • Khan AA, Perlstein I, Krishna R. The use of clinical utility assessments in early clinical development. AAPS J 2009;11(1):33-8
  • Zhang L. Dykstra K, Krishnaswami S. Communicating in a model-based drug development paradigm. AAPS Workshop ‘Quantitative pharmacology: a roadmap to model-based drug development’; November 10 2007; San Diego, CA, USA
  • Gobburu JV, Marroum PJ. Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making. Clin Pharmacokinet 2001;40(12):883-92
  • Wang Y, Bhattaram AV, Jadhav PR, Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006. J Clinical Pharmacol 2008;48(2):146-56
  • Lesko LJ. Paving the critical path: how can clinical pharmacology help achieve the vision? Clin Pharmacol Ther 2007;81(2):170-7
  • Jadhav PR, Zhang J, Gobburu JV. Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study. Pharm Stat 2009;8(3):216-24
  • US Food and Drug Administration. Exposure response relationships: guidance for industry. Rockville, MD; 2003
  • Li F, Nandy P, Chien S, Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children. Antimicrob Agents Chemother 2010;54(1):375-9

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.