메뉴 건너뛰기




Volumn 17, Issue 2, 2015, Pages 462-473

Preclinical Pharmacokinetic/Pharmacodynamic Modeling and Simulation in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape

(24)  Schuck, Edgar a   Bohnert, Tonika b   Chakravarty, Arijit c   Damian Iordache, Valeriu d   Gibson, Christopher e   Hsu, Cheng Pang f   Heimbach, Tycho g   Krishnatry, Anu Shilpa d   Liederer, Bianca M h   Lin, Jing i   Maurer, Tristan j   Mettetal, Jerome T k   Mudra, Daniel R l   Nijsen, Marjoleen JMA m   Raybon, Joseph n   Schroeder, Patricia o   Schuck, Virna k,r   Suryawanshi, Satyendra n   Su, Yaming p   Trapa, Patrick j   more..


Author keywords

pharmaceutical industry; preclinical pharmacokinetic pharmacodynamic modeling; simulation

Indexed keywords

BIOLOGICAL MODEL; COMPUTER SIMULATION; DOSE RESPONSE; DRUG DESIGN; DRUG DEVELOPMENT; DRUG INDUSTRY; HUMAN; INFORMATION PROCESSING; PRECLINICAL STUDY; PROCEDURES; STATISTICS AND NUMERICAL DATA;

EID: 84939957736     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9716-2     Document Type: Article
Times cited : (44)

References (18)
  • 1
    • 79955601786 scopus 로고    scopus 로고
    • Trial watch: phase II failures: 2008–2010
    • COI: 1:CAS:528:DC%2BC3MXlsVGlsbk%3D, PID: 21532551
    • Arrowsmith J. Trial watch: phase II failures: 2008–2010. Nat Rev Drug Discov. 2011;10:328–9. doi:10.1038/nrd3439.
    • (2011) Nat Rev Drug Discov , vol.10 , pp. 328-329
    • Arrowsmith, J.1
  • 2
    • 79551575056 scopus 로고    scopus 로고
    • Trial watch: phase III and submission failures: 2007–2010
    • COI: 1:CAS:528:DC%2BC3MXhtleksL8%3D, PID: 21283095
    • Arrowsmith J. Trial watch: phase III and submission failures: 2007–2010. Nat Rev Drug Discov. 2011;10:87. doi:10.1038/nrd3375.
    • (2011) Nat Rev Drug Discov , vol.10 , pp. 87
    • Arrowsmith, J.1
  • 3
    • 83555166044 scopus 로고    scopus 로고
    • Quantitative PK-PD model-based translational pharmacology of a novel kappa opioid receptor antagonist between rats and humans
    • COI: 1:CAS:528:DC%2BC3MXhsFamtr7O, PID: 21847689
    • Chang C, Byon W, Lu Y, Jacobsen LK, Badura LL, Sawant-Basak A, et al. Quantitative PK-PD model-based translational pharmacology of a novel kappa opioid receptor antagonist between rats and humans. AAPS J. 2011;13:565–75. doi:10.1208/s12248-011-9296-3.
    • (2011) AAPS J , vol.13 , pp. 565-575
    • Chang, C.1    Byon, W.2    Lu, Y.3    Jacobsen, L.K.4    Badura, L.L.5    Sawant-Basak, A.6
  • 4
    • 84926400433 scopus 로고    scopus 로고
    • Practical anticipation of human efficacious doses and pharmacokinetics using preclinical in vitro and in vivo data
    • Predictive ADMET: Integrated approaches in drug discovery and development. Wiley Inc.
    • Heimbach T, Gollen R, He H. Practical anticipation of human efficacious doses and pharmacokinetics using preclinical in vitro and in vivo data. In: Wang J, Urban L, editors. Predictive ADMET: Integrated approaches in drug discovery and development. Wiley Inc.; 2014. p. 319–352.
    • (2014) Wang J , pp. 319-352
    • Heimbach, T.1    Gollen, R.2    He, H.3    Urban, L.4
  • 5
    • 80052267476 scopus 로고    scopus 로고
    • PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 2: comparative assessment of prediction methods of human volume of distribution
    • COI: 1:CAS:528:DC%2BC3MXhtVylur%2FE, PID: 21452299
    • Jones RD, Jones HM, Rowland M, Gibson CR, Yates JW, Chien JY, et al. PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 2: comparative assessment of prediction methods of human volume of distribution. J Pharm Sci. 2011;100:4074–89.
    • (2011) J Pharm Sci , vol.100 , pp. 4074-4089
    • Jones, R.D.1    Jones, H.M.2    Rowland, M.3    Gibson, C.R.4    Yates, J.W.5    Chien, J.Y.6
  • 6
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • COI: 1:CAS:528:DC%2BD2cXmtVOhtLs%3D, PID: 15286737
    • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004;3:711–5.
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 7
    • 79959522607 scopus 로고    scopus 로고
    • Anti-arthritis effect of a novel Bruton’s tyrosine kinase inhibitor in Rat collagen-induced arthritis and mechanism-based pharmacokinetic/pharmacodynamic modeling: relationships between inhibition of BTK phosphorylation and efficacy
    • COI: 1:CAS:528:DC%2BC3MXosFCiu7w%3D, PID: 21521773
    • Liu L, Di Paolo J, Barbosa J, Rong H, Reif K, Wong H. Anti-arthritis effect of a novel Bruton’s tyrosine kinase inhibitor in Rat collagen-induced arthritis and mechanism-based pharmacokinetic/pharmacodynamic modeling: relationships between inhibition of BTK phosphorylation and efficacy. J Pharmacol Exp Ther. 2011;338:154–63. doi:10.1124/jpet.111.181545.
    • (2011) J Pharmacol Exp Ther , vol.338 , pp. 154-163
    • Liu, L.1    Di Paolo, J.2    Barbosa, J.3    Rong, H.4    Reif, K.5    Wong, H.6
  • 8
    • 83555164888 scopus 로고    scopus 로고
    • Pharmacodynamic model of sodium-glucose transporter 2 (SGLT2) inhibition: implications for quantitative translational pharmacology
    • COI: 1:CAS:528:DC%2BC3MXhsFamtr7I, PID: 21870203
    • Maurer TS, Ghosh A, Haddish-Berhane N, Sawant-Basak A, Boustany-Kari CM, She L, et al. Pharmacodynamic model of sodium-glucose transporter 2 (SGLT2) inhibition: implications for quantitative translational pharmacology. AAPS J. 2011;13:576–84. doi:10.1208/s12248-011-9297-2.
    • (2011) AAPS J , vol.13 , pp. 576-584
    • Maurer, T.S.1    Ghosh, A.2    Haddish-Berhane, N.3    Sawant-Basak, A.4    Boustany-Kari, C.M.5    She, L.6
  • 9
    • 0030799001 scopus 로고    scopus 로고
    • The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data
    • COI: 1:CAS:528:DyaK2sXmslCltr0%3D, PID: 9336307
    • Obach RS, Baxter JG, Liston TE, Silber BM, Jones BC, MacIntyre F, et al. The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther. 1997;283:46–58.
    • (1997) J Pharmacol Exp Ther , vol.283 , pp. 46-58
    • Obach, R.S.1    Baxter, J.G.2    Liston, T.E.3    Silber, B.M.4    Jones, B.C.5    MacIntyre, F.6
  • 10
    • 80052268294 scopus 로고    scopus 로고
    • PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 3: comparative assessement of prediction methods of human clearance
    • COI: 1:CAS:528:DC%2BC3MXhtVylurrK, PID: 21541938
    • Ring BJ, Chien JY, Adkison KK, Jones HM, Rowland M, Jones RD, et al. PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 3: comparative assessement of prediction methods of human clearance. J Pharm Sci. 2011;100:4090–110.
    • (2011) J Pharm Sci , vol.100 , pp. 4090-4110
    • Ring, B.J.1    Chien, J.Y.2    Adkison, K.K.3    Jones, H.M.4    Rowland, M.5    Jones, R.D.6
  • 11
    • 77955986074 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic modeling of tumor growth inhibition and biomarker modulation by the novel PI3K inhibitor 2-(1H-indazol-4-yl)-6-(4-methanesulfonyl-piperazin-1-ylmethyl)-4-morpholin-4-yl-thieno[3,2-d]pyrimidine (GDC-0941)
    • COI: 1:CAS:528:DC%2BC3cXhtFegu7zN, PID: 20538720
    • Salphati L, Wong H, Belvin M, Edgar KA, Prior WW, Sampath D, et al. Pharmacokinetic-pharmacodynamic modeling of tumor growth inhibition and biomarker modulation by the novel PI3K inhibitor 2-(1H-indazol-4-yl)-6-(4-methanesulfonyl-piperazin-1-ylmethyl)-4-morpholin-4-yl-thieno[3,2-d]pyrimidine (GDC-0941). Drug Metab Dispos. 2010;38:1436–42. doi:10.1124/dmd.110.032912.
    • (2010) Drug Metab Dispos , vol.38 , pp. 1436-1442
    • Salphati, L.1    Wong, H.2    Belvin, M.3    Edgar, K.A.4    Prior, W.W.5    Sampath, D.6
  • 12
    • 84881167489 scopus 로고    scopus 로고
    • White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation
    • COI: 1:STN:280:DC%2BC3sfktVSitg%3D%3D, PID: 23887723
    • Vlasakakis G, Comets E, Keunecke A, Gueorguieva I, Magni P, Terranova N, et al. White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation. CPT Pharmacometrics Syst Pharmacol. 2013;2:e40. doi:10.1038/psp.2013.16.
    • (2013) CPT Pharmacometrics Syst Pharmacol , vol.2 , pp. 40
    • Vlasakakis, G.1    Comets, E.2    Keunecke, A.3    Gueorguieva, I.4    Magni, P.5    Terranova, N.6
  • 13
    • 0035149324 scopus 로고    scopus 로고
    • Development of an in vivo preclinical screen model to estimate absorption and bioavailability of xenobiotics
    • COI: 1:CAS:528:DC%2BD3MXpvFKr, PID: 11124234
    • Ward KW, Proksch JW, Levy MA, Smith BR. Development of an in vivo preclinical screen model to estimate absorption and bioavailability of xenobiotics. Drug Metab Dispos. 2001;29:82–8.
    • (2001) Drug Metab Dispos , vol.29 , pp. 82-88
    • Ward, K.W.1    Proksch, J.W.2    Levy, M.A.3    Smith, B.R.4
  • 14
    • 9444234586 scopus 로고    scopus 로고
    • The chimpanzee (Pan troglodytes) as a pharmacokinetic model for selection of drug candidates: model characterization and application
    • COI: 1:CAS:528:DC%2BD2cXhtFGitrfK, PID: 15333515
    • Wong H, Grossman SJ, Bai SA, Diamond S, Wright MR, Grace Jr JE, et al. The chimpanzee (Pan troglodytes) as a pharmacokinetic model for selection of drug candidates: model characterization and application. Drug Metab Dispos. 2004;32:1359–69.
    • (2004) Drug Metab Dispos , vol.32 , pp. 1359-1369
    • Wong, H.1    Grossman, S.J.2    Bai, S.A.3    Diamond, S.4    Wright, M.R.5    Grace, J.E.6
  • 15
    • 84863904225 scopus 로고    scopus 로고
    • Anti-tumor activity of targeted and cytotoxic agents in murine subcutaneous tumor models correlates with clinical response
    • COI: 1:CAS:528:DC%2BC38XhtVelur%2FJ, PID: 22648270
    • Wong H, Choo EF, Alicke B, Ding X, La H, McNamara E, et al. Anti-tumor activity of targeted and cytotoxic agents in murine subcutaneous tumor models correlates with clinical response. Clin Cancer Res. 2012;18:3846–55. doi:10.1158/1078-0432.CCR-12-0738.
    • (2012) Clin Cancer Res , vol.18 , pp. 3846-3855
    • Wong, H.1    Choo, E.F.2    Alicke, B.3    Ding, X.4    La, H.5    McNamara, E.6
  • 16
    • 84861771818 scopus 로고    scopus 로고
    • Bridging the Gap between preclinical and clinical studies using PK-PD modeling: an analysis of GDC-0973, a MEK inhibitor
    • COI: 1:CAS:528:DC%2BC38XnvVOgtbg%3D, PID: 22496205
    • Wong H, Vernillet L, Peterson A, Ware JA, Lee L, Martini J-F, et al. Bridging the Gap between preclinical and clinical studies using PK-PD modeling: an analysis of GDC-0973, a MEK inhibitor. Clin Cancer Res. 2012;18:3090–9. doi:10.1158/1078-0432.CCR-12-0445.
    • (2012) Clin Cancer Res , vol.18 , pp. 3090-3099
    • Wong, H.1    Vernillet, L.2    Peterson, A.3    Ware, J.A.4    Lee, L.5    Martini, J.-F.6
  • 17
    • 84863116231 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic modeling of crizotinib for anaplastic lymphoma kinase inhibition and antitumor efficacy in human tumor xenograft mouse models
    • COI: 1:CAS:528:DC%2BC38XjtVSlu74%3D, PID: 22129595
    • Yamazaki S, Vicini P, Shen Z, Zou HY, Lee J, Li Q, et al. Pharmacokinetic/pharmacodynamic modeling of crizotinib for anaplastic lymphoma kinase inhibition and antitumor efficacy in human tumor xenograft mouse models. J Pharmacol Exp Ther. 2012;340:549–57.
    • (2012) J Pharmacol Exp Ther , vol.340 , pp. 549-557
    • Yamazaki, S.1    Vicini, P.2    Shen, Z.3    Zou, H.Y.4    Lee, J.5    Li, Q.6
  • 18
    • 84897581663 scopus 로고    scopus 로고
    • Preclinical PK/PD modeling and human efficacious dose projection for a glucokinase activator in the treatment of diabetes
    • COI: 1:CAS:528:DC%2BC2cXls1eitLc%3D, PID: 24578187
    • Zager MG, Kozminski K, Pascual B, Ogilvie KM, Sun S. Preclinical PK/PD modeling and human efficacious dose projection for a glucokinase activator in the treatment of diabetes. J Pharmacokinet Pharmacodyn. 2014;41:127–39. doi:10.1007/s10928-014-9351-7.
    • (2014) J Pharmacokinet Pharmacodyn , vol.41 , pp. 127-139
    • Zager, M.G.1    Kozminski, K.2    Pascual, B.3    Ogilvie, K.M.4    Sun, S.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.