메뉴 건너뛰기




Volumn 5, Issue 4, 2010, Pages 311-321

The current role of model-based drug development

Author keywords

Drug development; Modeling; Pharmacodynamics; Pharmacokinetics; Simulation

Indexed keywords

DRUG;

EID: 77950295526     PISSN: 17460441     EISSN: None     Source Type: Journal    
DOI: 10.1517/17460441003713470     Document Type: Review
Times cited : (25)

References (49)
  • 1
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev 2004;3(8):711-715
    • (2004) Nat Rev , vol.3 , Issue.8 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 2
    • 33751581755 scopus 로고    scopus 로고
    • Pipeline problems are increasing the urge to merge
    • Frantz S. Pipeline problems are increasing the urge to merge. Nat Rev 2006;5(12):977-979
    • (2006) Nat Rev , vol.5 , Issue.12 , pp. 977-979
    • Frantz, S.1
  • 5
    • 33745792813 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic modelling: History and perspectives
    • Csajka C, Verotta D. Pharmacokinetic-pharmacodynamic modelling: history and perspectives. J Pharmacokinet Pharmacodyn 2006;33(3):227-229
    • (2006) J Pharmacokinet Pharmacodyn , vol.33 , Issue.3 , pp. 227-229
    • Csajka, C.1    Verotta, D.2
  • 6
    • 0030890279 scopus 로고    scopus 로고
    • Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The "wooden shoe" paradigm
    • 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):259-267
    • (1997) Clin Pharmacokinet , vol.32 , Issue.4 , pp. 259-267
    • Breimer, D.D.1    Danhof, M.2
  • 7
    • 0036144662 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic studies in drug product development
    • Meibohm B, Derendorf H. Pharmacokinetic/pharmacodynamic studies in drug product development. J Pharm Sci 2002;91(1):18-31
    • (2002) J Pharm Sci , vol.91 , Issue.1 , pp. 18-31
    • Meibohm, B.1    Derendorf, H.2
  • 8
    • 0026663431 scopus 로고
    • Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development
    • Peck CC, Barr BW, Benet LZ, et al. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Pharm Res 1992;9(6):826-833
    • (1992) Pharm Res , vol.9 , Issue.6 , pp. 826-833
    • Peck, C.C.1    Barr, B.W.2    Benet, L.Z.3
  • 9
    • 0031003468 scopus 로고    scopus 로고
    • Learning versus confirming in clinical drug development
    • Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997;61(3):275-291
    • (1997) Clin Pharmacol Ther , vol.61 , Issue.3 , pp. 275-291
    • Sheiner, L.B.1
  • 10
    • 33747084052 scopus 로고    scopus 로고
    • Quantitative clinical pharmacology: Making paradigm shifts a reality
    • Krishna R. Quantitative clinical pharmacology: making paradigm shifts a reality. J Clin Pharmacol 2006;46(9):966-967
    • (2006) J Clin Pharmacol , vol.46 , Issue.9 , pp. 966-967
    • Krishna, R.1
  • 11
    • 0033397149 scopus 로고    scopus 로고
    • Viral kinetics and mathematical models
    • Perelson AS. Viral kinetics and mathematical models. Am J Med 1999;107(6B):49S-52S
    • (1999) Am J Med , vol.107 , Issue.6 B
    • Perelson, A.S.1
  • 12
    • 2442697903 scopus 로고    scopus 로고
    • Optimizing dose selection with modeling and simulation: Application to the vasopeptidase inhibitor M100240
    • 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):621-631
    • (2004) J Clin Pharmacol , vol.44 , Issue.6 , pp. 621-631
    • Pfister, M.1    Martin, N.E.2    Haskell, L.P.3    Barrett, J.S.4
  • 15
    • 0027466327 scopus 로고
    • A multiattribute-utility-function approach to weighing the risks and benefits of pharmaceutical agents
    • Eriksen S, Keller LR. A multiattribute-utility-function approach to weighing the risks and benefits of pharmaceutical agents. Med Decis Making 1993;13(2):118-125
    • (1993) Med Decis Making , vol.13 , Issue.2 , pp. 118-125
    • Eriksen, S.1    Keller, L.R.2
  • 16
    • 33745779940 scopus 로고    scopus 로고
    • Model-based drug development: The road to quantitative pharmacology
    • Zhang L, Sinha V, Forgue ST, et al. Model-based drug development: the road to quantitative pharmacology. J Pharmacokinet Pharmacodyn 2006;33(3):369-393
    • (2006) J Pharmacokinet Pharmacodyn , vol.33 , Issue.3 , pp. 369-393
    • Zhang, L.1    Sinha, V.2    Forgue, S.T.3
  • 17
    • 33646649531 scopus 로고    scopus 로고
    • Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications
    • Bhattaram VA, Booth BP, Ramchandani RP, et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J 2005;7(3):E503-12
    • (2005) AAPS J , vol.7 , Issue.3
    • Bhattaram, V.A.1    Booth, B.P.2    Ramchandani, R.P.3
  • 18
    • 65549156693 scopus 로고    scopus 로고
    • Concepts and challenges in quantitative pharmacology and model-based drug development
    • Zhang L, Pfister M, Meibohm B. Concepts and challenges in quantitative pharmacology and model-based drug development. AAPS J 2008;10(4):552-559
    • (2008) AAPS J , vol.10 , Issue.4 , pp. 552-559
    • Zhang, L.1    Pfister, M.2    Meibohm, B.3
  • 19
  • 21
    • 28244501254 scopus 로고    scopus 로고
    • How modeling and simulation have enhanced decision making in new drug development
    • Miller R, Ewy W, Corrigan BW, et al. How modeling and simulation have enhanced decision making in new drug development. J Pharmacokinet Pharmacodyn 2005;32(2):185-197
    • (2005) J Pharmacokinet Pharmacodyn , vol.32 , Issue.2 , pp. 185-197
    • Miller, R.1    Ewy, W.2    Corrigan, B.W.3
  • 22
    • 30444434228 scopus 로고    scopus 로고
    • Challenges in the transition to model-based development
    • Grasela TH, Fiedler-Kelly J, Walawander CA, et al. Challenges in the transition to model-based development. AAPS J 2005;7(2):488-495
    • (2005) AAPS J , vol.7 , Issue.2 , pp. 488-495
    • Grasela, T.H.1    Fiedler-Kelly, J.2    Walawander, C.A.3
  • 23
    • 63149182785 scopus 로고    scopus 로고
    • Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: Strategic considerations
    • Gabrielsson J, Dolgos H, Gillberg PG, et al. Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: strategic considerations. Drug Discov Today 2009;14(7-8):358-372
    • (2009) Drug Discov Today , vol.14 , Issue.7-8 , pp. 358-372
    • Gabrielsson, J.1    Dolgos, H.2    Gillberg, P.G.3
  • 24
    • 73349136256 scopus 로고    scopus 로고
    • Endpoints and analyses to discern disease-modifying drug effects in early Parkinson's disease
    • 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):456-464
    • (2009) AAPS J , vol.11 , Issue.3 , pp. 456-464
    • Bhattaram, V.A.1    Siddiqui, O.2    Kapcala, L.P.3    Gobburu, J.V.4
  • 25
    • 34247167585 scopus 로고    scopus 로고
    • Effective integration of systems biology, biomarkers, biosimulation and modelling in streamlining drug development
    • 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):62-67
    • (2007) Eur J Pharm Sci , vol.31 , Issue.1 , pp. 62-67
    • Krishna, R.1    Schaefer, H.G.2    Bjerrum, O.J.3
  • 26
    • 39049185309 scopus 로고    scopus 로고
    • Using exposure-response and biomarkers to streamline early drug development
    • Venitz J. Using exposure-response and biomarkers to streamline early drug development. Ernst Schering Res Found Workshop 2007;59(1):47-63
    • (2007) Ernst Schering Res Found Workshop , vol.59 , Issue.1 , pp. 47-63
    • Venitz, J.1
  • 27
    • 33846573411 scopus 로고    scopus 로고
    • Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006
    • Bhattaram VA, Bonapace C, Chilukuri DM, et al. 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):213-221
    • (2007) Clin Pharmacol Ther , vol.81 , Issue.2 , pp. 213-221
    • Bhattaram, V.A.1    Bonapace, C.2    Chilukuri, D.M.3
  • 28
    • 0028075942 scopus 로고
    • Mechanism-based pharmacodynamic modeling
    • Levy G. Mechanism-based pharmacodynamic modeling. Clin Pharmacol Ther 1994;56(4):356-358
    • (1994) Clin Pharmacol Ther , vol.56 , Issue.4 , pp. 356-358
    • Levy, G.1
  • 29
    • 0034119297 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic modeling in drug development
    • Sheiner LB, Steimer JL. Pharmacokinetic/pharmacodynamic modeling in drug development. Ann Rev Pharmacol Toxicol 2000;40:67-95
    • (2000) Ann Rev Pharmacol Toxicol , vol.40 , pp. 67-95
    • Sheiner, L.B.1    Steimer, J.L.2
  • 30
    • 0007868865 scopus 로고    scopus 로고
    • Effective incorporation of preclinical information into the decision making process for new drug development: An anonymous case study
    • Bies R, Ko HC, Gobburu J, et al. 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
    • (2000) Clin Pharmacol Ther , vol.67 , Issue.2 , pp. 107
    • Bies, R.1    Ko, H.C.2    Gobburu, J.3
  • 31
    • 33644808298 scopus 로고    scopus 로고
    • Pharmacokinetics/ pharmacodynamics and the stages of drug development: Role of modeling and simulation
    • Chien JY, Friedrich S, Heathman MA, et al. Pharmacokinetics/ pharmacodynamics and the stages of drug development: role of modeling and simulation. AAPS J 2005;7(3):544-559
    • (2005) AAPS J , vol.7 , Issue.3 , pp. 544-559
    • Chien, J.Y.1    Friedrich, S.2    Heathman, M.A.3
  • 32
    • 53849084784 scopus 로고    scopus 로고
    • Use of quantitative pharmacology in the development of HAE1, a high-affinity anti-IgE monoclonal antibody
    • Putnam WS, Li J, Haggstrom J, et al. Use of quantitative pharmacology in the development of HAE1, a high-affinity anti-IgE monoclonal antibody. AAPS J 2008;10(2):425-430
    • (2008) AAPS J , vol.10 , Issue.2 , pp. 425-430
    • Putnam, W.S.1    Li, J.2    Haggstrom, J.3
  • 33
    • 0035038023 scopus 로고    scopus 로고
    • Drug treatment effects on disease progression
    • Chan PL, Holford NH. Drug treatment effects on disease progression. Ann Rev Pharmacol Toxicol 2001;41:625-659
    • (2001) Ann Rev Pharmacol Toxicol , vol.41 , pp. 625-659
    • Chan, P.L.1    Holford, N.H.2
  • 34
  • 35
    • 73349127010 scopus 로고    scopus 로고
    • Washout and delayed start designs for identifying disease modifying effects in slowly progressive diseases using disease progression analysis
    • 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):225-238
    • (2009) Pharm Stat , vol.8 , Issue.3 , pp. 225-238
    • Ploeger, B.A.1    Holford, N.H.2
  • 36
    • 77950205248 scopus 로고    scopus 로고
    • A semi-mechanistic model of CP-690,550-induced reduction in neutrophil counts in patients with rheumatoid arthritis
    • [Epub ahead of print]
    • Gupta P, Friberg LE, Karlsson MO, et al. 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]
    • (2009) J Clin Pharmacol
    • Gupta, P.1    Friberg, L.E.2    Karlsson, M.O.3
  • 37
    • 0002002390 scopus 로고    scopus 로고
    • Clinical trial simulation: Streamlining your drug development process
    • Hale MD GW, Gupta SK, Tuk B, Holford NH. Clinical trial simulation: streamlining your drug development process. Appl Clin Trials 1996;5:35-40
    • (1996) Appl Clin Trials , vol.5 , pp. 35-40
    • Hale Md, G.W.1    Gupta, S.K.2    Tuk, B.3    Holford, N.H.4
  • 38
    • 0036783184 scopus 로고    scopus 로고
    • Clinical trial simulation of a 200-microg fixed dose of darbepoetin alfa in chemotherapy-induced anemia
    • Jumbe N, Yao B, Rovetti R, et al. 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
    • (2002) Oncology (Williston Park) , vol.16 , Issue.10 SUPPL. 11 , pp. 37-44
    • Jumbe, N.1    Yao, B.2    Rovetti, R.3
  • 39
    • 1542346485 scopus 로고    scopus 로고
    • 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
    • Thames WA, Smith SL, Scheifele AC, et al. 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):313-323
    • (2004) Pharmacotherapy , vol.24 , Issue.3 , pp. 313-323
    • Thames, W.A.1    Smith, S.L.2    Scheifele, A.C.3
  • 40
    • 33750590174 scopus 로고    scopus 로고
    • 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
    • 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):2050-2059
    • (2006) Pharm Res , vol.23 , Issue.9 , pp. 2050-2059
    • Lockwood, P.1    Ewy, W.2    Hermann, D.3    Holford, N.4
  • 41
    • 0035889726 scopus 로고    scopus 로고
    • Combining drug-disease and economic modelling to inform drug development decisions
    • Poland B, Wada R. Combining drug-disease and economic modelling to inform drug development decisions. Drug Discov Today 2001;6(22):1165-1170
    • (2001) Drug Discov Today , vol.6 , Issue.22 , pp. 1165-1170
    • Poland, B.1    Wada, R.2
  • 42
    • 65549162224 scopus 로고    scopus 로고
    • The use of clinical utility assessments in early clinical development
    • Khan AA, Perlstein I, Krishna R. The use of clinical utility assessments in early clinical development. AAPS J 2009;11(1):33-38
    • (2009) AAPS J , vol.11 , Issue.1 , pp. 33-38
    • Khan, A.A.1    Perlstein, I.2    Krishna, R.3
  • 44
    • 0035693563 scopus 로고    scopus 로고
    • Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making
    • Gobburu JV, Marroum PJ. Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making. Clin Pharmacokinet 2001;40(12):883-892
    • (2001) Clin Pharmacokinet , vol.40 , Issue.12 , pp. 883-892
    • Gobburu, J.V.1    Marroum, P.J.2
  • 45
    • 38349115335 scopus 로고    scopus 로고
    • Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: Impact of FDA pharmacometrics during 2004-2006
    • Wang Y, Bhattaram AV, Jadhav PR, et al. 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):146-156
    • (2008) J Clinical Pharmacol , vol.48 , Issue.2 , pp. 146-156
    • Wang, Y.1    Bhattaram, A.V.2    Jadhav, P.R.3
  • 46
    • 33846600867 scopus 로고    scopus 로고
    • Paving the critical path: How can clinical pharmacology help achieve the vision?
    • Lesko LJ. Paving the critical path: how can clinical pharmacology help achieve the vision? Clin Pharmacol Ther 2007;81(2):170-177
    • (2007) Clin Pharmacol Ther , vol.81 , Issue.2 , pp. 170-177
    • Lesko, L.J.1
  • 47
    • 73349143952 scopus 로고    scopus 로고
    • Leveraging prior quantitative knowledge in guiding pediatric drug development: A case study
    • Jadhav PR, Zhang J, Gobburu JV. Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study. Pharm Stat 2009;8(3):216-224
    • (2009) Pharm Stat , vol.8 , Issue.3 , pp. 216-224
    • Jadhav, P.R.1    Zhang, J.2    Gobburu, J.V.3
  • 49
    • 73849139599 scopus 로고    scopus 로고
    • Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children
    • Li F, Nandy P, Chien S, et al. Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children. Antimicrob Agents Chemother 2010;54(1):375-379
    • (2010) Antimicrob Agents Chemother , vol.54 , Issue.1 , pp. 375-379
    • Li, F.1    Nandy, P.2    Chien, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.