-
1
-
-
79957889347
-
The productivity crisis in pharmaceutical R&D
-
[1] Pammolli, F., Magazzini, L., Riccaboni, M., The productivity crisis in pharmaceutical R&D. Nat Rev Drug Discov 10:6 (2011), 428–438, 10.1038/nrd3405.
-
(2011)
Nat Rev Drug Discov
, vol.10
, Issue.6
, pp. 428-438
-
-
Pammolli, F.1
Magazzini, L.2
Riccaboni, M.3
-
2
-
-
1242330795
-
2003 approvals: a year of innovation and upward trends
-
[2] Frantz, S., 2003 approvals: a year of innovation and upward trends. Nat Rev Drug Discov 3:2 (2004), 103–105, 10.1038/nrd1327.
-
(2004)
Nat Rev Drug Discov
, vol.3
, Issue.2
, pp. 103-105
-
-
Frantz, S.1
-
3
-
-
73449101512
-
Lessons from 60 years of pharmaceutical innovation
-
[3] Munos, B., Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov 8:12 (2009), 959–968, 10.1038/nrd2961.
-
(2009)
Nat Rev Drug Discov
, vol.8
, Issue.12
, pp. 959-968
-
-
Munos, B.1
-
4
-
-
84923777144
-
“New drug” designations for new therapeutic entities: new active substance, new chemical entity, new biological entity, new molecular entity
-
[4] Branch, S.K., Agranat, I., “New drug” designations for new therapeutic entities: new active substance, new chemical entity, new biological entity, new molecular entity. J Med Chem 57:21 (2014), 8729–8765, 10.1021/jm402001w.
-
(2014)
J Med Chem
, vol.57
, Issue.21
, pp. 8729-8765
-
-
Branch, S.K.1
Agranat, I.2
-
5
-
-
84857743319
-
Diagnosing the decline in pharmaceutical R&D efficiency
-
[5] Scannell, J.W., Blanckley, A., Boldon, H., Warrington, B., Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov 11:3 (2012), 191–200, 10.1038/nrd3681.
-
(2012)
Nat Rev Drug Discov
, vol.11
, Issue.3
, pp. 191-200
-
-
Scannell, J.W.1
Blanckley, A.2
Boldon, H.3
Warrington, B.4
-
6
-
-
12144268237
-
Macro trends in pharmaceutical innovation
-
[6] Cohen, F.J., Macro trends in pharmaceutical innovation. Nat Rev Drug Discov 4:1 (2005), 78–84, 10.1038/nrd1610.
-
(2005)
Nat Rev Drug Discov
, vol.4
, Issue.1
, pp. 78-84
-
-
Cohen, F.J.1
-
7
-
-
84929324239
-
Innovation in the pharmaceutical industry: new estimates of R&D costs,
-
R&D cost study briefing, Tufts Center for the Study of Drug Development (TCSDD), November 18, 2014. Available from:.
-
[7] DiMasi J A, Innovation in the pharmaceutical industry: new estimates of R&D costs, In: R&D cost study briefing, Tufts Center for the Study of Drug Development (TCSDD), November 18, 2014. Available from: http://csdd.tufts.edu/files/uploads/Tufts_CSDD_briefing_on_RD_cost_study_-_Nov_18,_2014.pdf.
-
-
-
DiMasi, J.A.1
-
8
-
-
84991592771
-
-
2015 Biopharmaceutical research industry profile. Pharmaceutical Research and Manufacturers of America (PhRMA), 2015. Available from:.
-
[8] 2015 Biopharmaceutical research industry profile. Pharmaceutical Research and Manufacturers of America (PhRMA), 2015. Available from: http://www.phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf.
-
-
-
-
9
-
-
84991592785
-
U.S. Food and Drug Administration Center of Drug Evaluation and Research, 2015
-
Available from
-
[9] Summary, Novel Drugs, U.S. Food and Drug Administration Center of Drug Evaluation and Research, 2015., 2015 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM485053.pdf Available from.
-
(2015)
-
-
Summary, N.D.1
-
10
-
-
4344645978
-
Can the pharmaceutical industry reduce attrition rates?
-
[10] Kola, I., Landis, J., Can the pharmaceutical industry reduce attrition rates?. Nature reviews Drug discovery 3:8 (2004), 711–716, 10.1038/nrd1470.
-
(2004)
Nature reviews Drug discovery
, vol.3
, Issue.8
, pp. 711-716
-
-
Kola, I.1
Landis, J.2
-
11
-
-
84934439985
-
An analysis of the attrition of drug candidates from four major pharmaceutical companies
-
[11] Waring, M.J., Arrowsmith, J., Leach, A.R., Leeson, P.D., Mandrell, S., Owen, R.M., An analysis of the attrition of drug candidates from four major pharmaceutical companies. Nat Rev Drug Discov 14:7 (2015), 475–486, 10.1038/nrd4609.
-
(2015)
Nat Rev Drug Discov
, vol.14
, Issue.7
, pp. 475-486
-
-
Waring, M.J.1
Arrowsmith, J.2
Leach, A.R.3
Leeson, P.D.4
Mandrell, S.5
Owen, R.M.6
-
12
-
-
84892153139
-
Clinical development success rates for investigational drugs
-
[12] Hay, M., Thomas, D.W., Craighead, J.L., Economides, C., Rosenthal, J., Clinical development success rates for investigational drugs. Nat Biotechnol 32:1 (2014), 40–51, 10.1038/nbt.2786.
-
(2014)
Nat Biotechnol
, vol.32
, Issue.1
, pp. 40-51
-
-
Hay, M.1
Thomas, D.W.2
Craighead, J.L.3
Economides, C.4
Rosenthal, J.5
-
13
-
-
84901946024
-
Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework
-
[13] Cook, D., Brown, D., Alexander, R., March, R., Morgan, P., Satterthwaite, G., Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework. Nat Rev Drug Discov 13:6 (2014), 419–431, 10.1038/nrd4309.
-
(2014)
Nat Rev Drug Discov
, vol.13
, Issue.6
, pp. 419-431
-
-
Cook, D.1
Brown, D.2
Alexander, R.3
March, R.4
Morgan, P.5
Satterthwaite, G.6
-
14
-
-
84960856818
-
Good practices in model-informed drug discovery and development: practice, application, and documentation
-
[14] Marshall, S., Burghaus, R., Cosson, V., Cheung, S., Chenel, M., Good practices in model-informed drug discovery and development: practice, application, and documentation. CPT,: Pharmacometrics & Syst Pharmacol 5:3 (2016), 93–122, 10.1002/psp4.12049.
-
(2016)
CPT,: Pharmacometrics & Syst Pharmacol
, vol.5
, Issue.3
, pp. 93-122
-
-
Marshall, S.1
Burghaus, R.2
Cosson, V.3
Cheung, S.4
Chenel, M.5
-
15
-
-
84926498217
-
Implementation of quantitative and systems pharmacology in large pharma
-
[15] Visser, S.A.G., de Alwis, D.P., Kerbusch, T., Stone, J.A., Allerheiligen, S.R.B., Implementation of quantitative and systems pharmacology in large pharma. CPT, Pharmacometrics Syst Pharmacol, 3(10), 2014, e142, 10.1038/psp.2014.40.
-
(2014)
CPT, Pharmacometrics Syst Pharmacol
, vol.3
, Issue.10
, pp. e142
-
-
Visser, S.A.G.1
de Alwis, D.P.2
Kerbusch, T.3
Stone, J.A.4
Allerheiligen, S.R.B.5
-
16
-
-
84878238854
-
Model-based drug development: a rational approach to efficiently accelerate drug development
-
[16] Milligan, P.A., Brown, M.J., Marchant, B., Martin, S.W., van der Graaf, P.H., Model-based drug development: a rational approach to efficiently accelerate drug development. Clin Pharmacol Ther 93:6 (2013), 502–514, 10.1038/clpt.2013.54.
-
(2013)
Clin Pharmacol Ther
, vol.93
, Issue.6
, pp. 502-514
-
-
Milligan, P.A.1
Brown, M.J.2
Marchant, B.3
Martin, S.W.4
van der Graaf, P.H.5
-
17
-
-
84881037647
-
Modeling and simulation at the interface of nonclinical and early clinical drug development
-
[17] Visser, S.A.G., Manolis, E., Danhof, M., Kerbusch, T., Modeling and simulation at the interface of nonclinical and early clinical drug development. CPT: Pharmacometrics & Syst Pharmacol, 2(2), 2013, e30, 10.1038/psp.2013.3.
-
(2013)
CPT: Pharmacometrics & Syst Pharmacol
, vol.2
, Issue.2
, pp. e30
-
-
Visser, S.A.G.1
Manolis, E.2
Danhof, M.3
Kerbusch, T.4
-
18
-
-
84881167602
-
Model-based drug discovery: implementation and impact
-
[18] Visser, S.A., Aurell, M., Jones, R.D., Schuck, V.J., Egnell, A.-C., Model-based drug discovery: implementation and impact. Drug Discov Today 18:15-16 (2013), 764–775, 10.1016/j.drudis.2013.05.012.
-
(2013)
Drug Discov Today
, vol.18
, Issue.15-16
, pp. 764-775
-
-
Visser, S.A.1
Aurell, M.2
Jones, R.D.3
Schuck, V.J.4
Egnell, A.-C.5
-
19
-
-
84952638889
-
How computational models can help unlock biological systems
-
[19] Brodland, G.W., How computational models can help unlock biological systems. Semin Cell Dev Biol 47-48 (2015), 62–73, 10.1016/j.semcdb.2015.07.001.
-
(2015)
Semin Cell Dev Biol
, vol.47-48
, pp. 62-73
-
-
Brodland, G.W.1
-
20
-
-
33747812085
-
Applying computational modeling to drug discovery and development
-
[20] Kumar, N., Hendriks, B.S., Janes, K.A., de Graaf, D., Lauffenburger, D.A., Applying computational modeling to drug discovery and development. Drug Discov Today 11:17-18 (2006), 806–811, 10.1016/j.drudis.2006.07.010.
-
(2006)
Drug Discov Today
, vol.11
, Issue.17-18
, pp. 806-811
-
-
Kumar, N.1
Hendriks, B.S.2
Janes, K.A.3
de Graaf, D.4
Lauffenburger, D.A.5
-
21
-
-
0001146538
-
Kinetics of distribution of substances administered to the body, I: the extravascular modes of administration
-
[21] Teorell, T., Kinetics of distribution of substances administered to the body, I: the extravascular modes of administration. Arch Int Pharmacodyn Ther 57 (1937), 205–225.
-
(1937)
Arch Int Pharmacodyn Ther
, vol.57
, pp. 205-225
-
-
Teorell, T.1
-
22
-
-
0001146538
-
Kinetics of distribution of substances administered to the body, II: the intravascular modes of administration
-
[22] Teorell, T., Kinetics of distribution of substances administered to the body, II: the intravascular modes of administration. Arch Int Pharmacodyn Ther 57 (1937), 226–240.
-
(1937)
Arch Int Pharmacodyn Ther
, vol.57
, pp. 226-240
-
-
Teorell, T.1
-
23
-
-
0029173963
-
Torsten teorell, the father of pharmacokinetics
-
[23] Paalzow, L.K., Torsten teorell, the father of pharmacokinetics. Ups J Med Sci 100:1 (1995), 41–46, 10.3109/03009739509178895.
-
(1995)
Ups J Med Sci
, vol.100
, Issue.1
, pp. 41-46
-
-
Paalzow, L.K.1
-
24
-
-
85032057407
-
Foreword.
-
N.R. Cutler J.J. Sramek P.K. Narang Chichester: Wiley
-
[24] Benet, L.Z., Foreword. Cutler, N.R., Sramek, J.J., Narang, P.K., (eds.) Pharmacodynamics and drug development: perspectives in clinical pharmacology, 1994, Chichester: Wiley, xiii–xv.
-
(1994)
Pharmacodynamics and drug development: perspectives in clinical pharmacology
, pp. xiii-xv
-
-
Benet, L.Z.1
-
25
-
-
84991707978
-
Applications of pharmacokinetic principles in drug development
-
Springer US, Boston, MA
-
[25] Rohatagi, S., Martin, N.E., Barrett, J.S., Applications of pharmacokinetic principles in drug development. Ch. Pharmacokinetic/Pharmacodynamic Modeling in Drug Development, 2004, Springer, US, Boston, MA, 333–372, 10.1007/978-1-4419-9216-1_11.
-
(2004)
Ch. Pharmacokinetic/Pharmacodynamic Modeling in Drug Development
, pp. 333-372
-
-
Rohatagi, S.1
Martin, N.E.2
Barrett, J.S.3
-
26
-
-
52649130373
-
Whole body physiologically-based pharmacokinetic models: their use in clinical drug development
-
[26] Edginton, A.N., Theil, F.-P., Schmitt, W., Willmann, S., Whole body physiologically-based pharmacokinetic models: their use in clinical drug development. Expert Opin Drug Metab Toxicol 4:9 (2008), 1143–1152, 10.1517/17425255.4.9.1143.
-
(2008)
Expert Opin Drug Metab Toxicol
, vol.4
, Issue.9
, pp. 1143-1152
-
-
Edginton, A.N.1
Theil, F.-P.2
Schmitt, W.3
Willmann, S.4
-
27
-
-
73449088412
-
Physiologically based pharmacokinetics (PBPK)
-
[27] Espié, P., Tytgat, D., Sargentini-Maier, M.-L., Poggesi, I., Watelet, J.-B., Physiologically based pharmacokinetics (PBPK). Drug Metab Rev 41:3 (2009), 391–407, 10.1080/10837450902891360.
-
(2009)
Drug Metab Rev
, vol.41
, Issue.3
, pp. 391-407
-
-
Espié, P.1
Tytgat, D.2
Sargentini-Maier, M.-L.3
Poggesi, I.4
Watelet, J.-B.5
-
28
-
-
80052495952
-
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008
-
[28] Lee, J.Y., Garnett, C.E., Gobburu, J.V., Bhattaram, V.A., Brar, S., Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin Pharmacokinet 50:10 (2011), 627–635, 10.2165/11593210-000000000-00000.
-
(2011)
Clin Pharmacokinet
, vol.50
, Issue.10
, pp. 627-635
-
-
Lee, J.Y.1
Garnett, C.E.2
Gobburu, J.V.3
Bhattaram, V.A.4
Brar, S.5
-
29
-
-
33846573411
-
Impact of pharmacometric reviews on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006
-
[29] Bhattaram, V.A., Bonapace, C., Chilukuri, D.M., Duan, J.Z., Garnett, C., 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 81:2 (2007), 213–221, 10.1038/sj.clpt.6100051.
-
(2007)
Clin Pharmacol Ther
, vol.81
, Issue.2
, pp. 213-221
-
-
Bhattaram, V.A.1
Bonapace, C.2
Chilukuri, D.M.3
Duan, J.Z.4
Garnett, C.5
-
30
-
-
33646649531
-
Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications
-
[30] Bhattaram, V.A., Booth, B.P., Ramchandani, R.P., Beasley, B.N., Wang, Y., Tandon, V., Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J 7:3 (2005), E503–E512, 10.1208/aapsj070351.
-
(2005)
AAPS J
, vol.7
, Issue.3
, pp. E503-E512
-
-
Bhattaram, V.A.1
Booth, B.P.2
Ramchandani, R.P.3
Beasley, B.N.4
Wang, Y.5
Tandon, V.6
-
31
-
-
35649001607
-
A quantitative description of membrane current and its application to conduction and excitation in nerve
-
[31] Hodgkin, A.L., Huxley, A.F., A quantitative description of membrane current and its application to conduction and excitation in nerve. J Physiol (Lond) 117:4 (1952), 500–544.
-
(1952)
J Physiol (Lond)
, vol.117
, Issue.4
, pp. 500-544
-
-
Hodgkin, A.L.1
Huxley, A.F.2
-
32
-
-
79955439683
-
Making sense of the data explosion: the promise of systems science
-
[32] Mabry, P.L., Making sense of the data explosion: the promise of systems science. Am J Prev Med 40:5 Suppl 2 (2011), S159–161, 10.1016/j.amepre.2011.02.001.
-
(2011)
Am J Prev Med
, vol.40
, Issue.5
, pp. S159-161
-
-
Mabry, P.L.1
-
33
-
-
0036500993
-
Systems biology: a brief overview
-
[33] Kitano, H., Systems biology: a brief overview. Science 295:5560 (2002), 1662–1664, 10.1126/science.1069492.
-
(2002)
Science
, vol.295
, Issue.5560
, pp. 1662-1664
-
-
Kitano, H.1
-
34
-
-
37849020261
-
Network inference, analysis, and modeling in systems biology
-
[34] Albert, R., Network inference, analysis, and modeling in systems biology. Plant Cell 19:11 (2007), 3327–3338, 10.1105/tpc.107.054700.
-
(2007)
Plant Cell
, vol.19
, Issue.11
, pp. 3327-3338
-
-
Albert, R.1
-
35
-
-
77953809572
-
Next-generation model-based drug discovery and development: quantitative and systems pharmacology
-
[35] Allerheiligen, S.R.B., Next-generation model-based drug discovery and development: quantitative and systems pharmacology. Clin Pharmacol Ther 88:1 (2010), 135–137, 10.1038/clpt.2010.81.
-
(2010)
Clin Pharmacol Ther
, vol.88
, Issue.1
, pp. 135-137
-
-
Allerheiligen, S.R.B.1
-
36
-
-
84871344105
-
Quantitative and systems pharmacology in the post-genomic era: new approaches to discovering drugs and understanding therapeutic mechanisms
-
NIH Bethesda
-
[36] Sorger, P.K., Allerheiligen, S.R., Abernethy, D.R., Altman, R.B., Brouwer, K.L., Quantitative and systems pharmacology in the post-genomic era: new approaches to discovering drugs and understanding therapeutic mechanisms. An NIH white paper by the QSP workshop group, 2011, NIH Bethesda, 1–48.
-
(2011)
An NIH white paper by the QSP workshop group
, pp. 1-48
-
-
Sorger, P.K.1
Allerheiligen, S.R.2
Abernethy, D.R.3
Altman, R.B.4
Brouwer, K.L.5
-
37
-
-
84958818119
-
Requirements for multi-level systems pharmacology models to reach end-usage: the case of type 2 diabetes
-
[37] Nyman, E., Rozendaal, Y.J.W., Helmlinger, G., Hamrén, B., Kjellsson, M.C., Requirements for multi-level systems pharmacology models to reach end-usage: the case of type 2 diabetes. Interface Focus, 6(2), 2016, 20150075, 10.1098/rsfs.2015.0075.
-
(2016)
Interface Focus
, vol.6
, Issue.2
, pp. 20150075
-
-
Nyman, E.1
Rozendaal, Y.J.W.2
Helmlinger, G.3
Hamrén, B.4
Kjellsson, M.C.5
-
38
-
-
82255183162
-
Integration not isolation: arguing the case for quantitative and systems pharmacology in drug discovery and development
-
[38] Agoram, B.M., Demin, O., Integration not isolation: arguing the case for quantitative and systems pharmacology in drug discovery and development. Drug Discov Today 16:23-24 (2011), 1031–1036, 10.1016/j.drudis.2011.10.001.
-
(2011)
Drug Discov Today
, vol.16
, Issue.23-24
, pp. 1031-1036
-
-
Agoram, B.M.1
Demin, O.2
-
39
-
-
84936753153
-
FDA advisory meeting clinical pharmacology review utilizes a quantitative systems pharmacology (QSP) model: a watershed moment?
-
[39] Peterson, M.C., Riggs, M.M., FDA advisory meeting clinical pharmacology review utilizes a quantitative systems pharmacology (QSP) model: a watershed moment?. CPT Pharmacometrics Syst Pharmacol, 4(3), 2015, e00020, 10.1002/psp4.20.
-
(2015)
CPT Pharmacometrics Syst Pharmacol
, vol.4
, Issue.3
, pp. e00020
-
-
Peterson, M.C.1
Riggs, M.M.2
-
40
-
-
79959900575
-
Systems pharmacology: bridging systems biology and pharmacokinetics-pharmacodynamics (PKPD) in drug discovery and development
-
[40] van der Graaf, P.H., Benson, N., Systems pharmacology: bridging systems biology and pharmacokinetics-pharmacodynamics (PKPD) in drug discovery and development. Pharm Res 28:7 (2011), 1460–1464, 10.1007/s11095-011-0467-9.
-
(2011)
Pharm Res
, vol.28
, Issue.7
, pp. 1460-1464
-
-
van der Graaf, P.H.1
Benson, N.2
-
41
-
-
84892364548
-
Systems pharmacology modeling: an approach to improving drug safety
-
[41] Bai, J.P.F., Fontana, R.J., Price, N.D., Sangar, V., Systems pharmacology modeling: an approach to improving drug safety. Biopharm Drug Dispos 35:1 (2013), 1–14, 10.1002/bdd.1871.
-
(2013)
Biopharm Drug Dispos
, vol.35
, Issue.1
, pp. 1-14
-
-
Bai, J.P.F.1
Fontana, R.J.2
Price, N.D.3
Sangar, V.4
-
42
-
-
33644877164
-
BioModels database: a free, centralized database of curated, published, quantitative kinetic models of biochemical and cellular systems
-
[42] Le Novère, N., Bornstein, B., Broicher, A., Courtot, M., Donizelli, M., BioModels database: a free, centralized database of curated, published, quantitative kinetic models of biochemical and cellular systems. Nucleic Acids Res 34:Database issue (2006), D689–D691, 10.1093/nar/gkj092.
-
(2006)
Nucleic Acids Res
, vol.34
, Issue.Database issue
, pp. D689-D691
-
-
Le Novère, N.1
Bornstein, B.2
Broicher, A.3
Courtot, M.4
Donizelli, M.5
-
43
-
-
84941113365
-
Biomodels: ten-year anniversary
-
[43] Chelliah, V., Juty, N., Ajmera, I., Ali, R., Dumousseau, M., Biomodels: ten-year anniversary. Nucleic Acids Res 43 (2015), D542–D548, 10.1093/nar/gku1181.
-
(2015)
Nucleic Acids Res
, vol.43
, pp. D542-D548
-
-
Chelliah, V.1
Juty, N.2
Ajmera, I.3
Ali, R.4
Dumousseau, M.5
-
44
-
-
84881162079
-
The impact of mathematical modeling on the understanding of diabetes and related complications
-
[44] Ajmera, I., Swat, M., Laibe, C., Novère, N.L., Chelliah, V., The impact of mathematical modeling on the understanding of diabetes and related complications. CPT: Pharmacometrics & Syst Pharmacol, 2(7), 2013, e54, 10.1038/psp.2013.30.
-
(2013)
CPT: Pharmacometrics & Syst Pharmacol
, vol.2
, Issue.7
, pp. e54
-
-
Ajmera, I.1
Swat, M.2
Laibe, C.3
Novère, N.L.4
Chelliah, V.5
-
45
-
-
72149104599
-
A physiologically based mathematical model of integrated calcium homeostasis and bone remodeling
-
[45] Peterson, M.C., Riggs, M.M., A physiologically based mathematical model of integrated calcium homeostasis and bone remodeling. Bone 46:1 (2010), 49–63, 10.1016/j.bone.2009.08.053.
-
(2010)
Bone
, vol.46
, Issue.1
, pp. 49-63
-
-
Peterson, M.C.1
Riggs, M.M.2
-
46
-
-
84991609389
-
Clinical pharmacology assessment: adequacy of natpara dosage regimen in treatment of hypothyroidism
-
[46] Khurana, M., Mehrotra, N., Zadezensky, I., Clinical pharmacology assessment: adequacy of natpara dosage regimen in treatment of hypothyroidism. Endocrinologic and metabolic drugs advisory committee meeting 2014, endocrinologic and metabolic drugs advisory committee, office of clinical pharmacology, 2014, 136–144.
-
(2014)
Endocrinologic and metabolic drugs advisory committee meeting 2014, endocrinologic and metabolic drugs advisory committee, office of clinical pharmacology
, pp. 136-144
-
-
Khurana, M.1
Mehrotra, N.2
Zadezensky, I.3
-
47
-
-
84880385696
-
A hybrid cellular automaton model of solid tumor growth and bioreductive drug transport
-
[47] Kazmi, N., Hossain, M.A., Phillips, R.M., A hybrid cellular automaton model of solid tumor growth and bioreductive drug transport. IEEE/ACM Trans Comput Biol Bioinform 9:6 (2012), 1595–1606, 10.1109/TCBB.2012.118.
-
(2012)
IEEE/ACM Trans Comput Biol Bioinform
, vol.9
, Issue.6
, pp. 1595-1606
-
-
Kazmi, N.1
Hossain, M.A.2
Phillips, R.M.3
-
48
-
-
84957824506
-
Delivery of cancer therapeutics to extracellular and intracellular targets: determinants, barriers, challenges and opportunities
-
[48] Au, J.L., Yeung, B.Z., Wientjes, M.G., Lu, Z., Wientjes, M.G., Delivery of cancer therapeutics to extracellular and intracellular targets: determinants, barriers, challenges and opportunities. Adv Drug Deliv Rev 97 (2016), 280–301, 10.1016/j.addr.2015.12.002.
-
(2016)
Adv Drug Deliv Rev
, vol.97
, pp. 280-301
-
-
Au, J.L.1
Yeung, B.Z.2
Wientjes, M.G.3
Lu, Z.4
Wientjes, M.G.5
-
49
-
-
84926498218
-
Quantitative insight in utilizing circulating angiogenic factors as biomarkers for antiangiogenic therapy: systems pharmacology approach
-
[49] Sharan, S., Woo, S., Quantitative insight in utilizing circulating angiogenic factors as biomarkers for antiangiogenic therapy: systems pharmacology approach. CPT Pharmacometrics Syst Pharmacol, 3, 2014, e139, 10.1038/psp.2014.36.
-
(2014)
CPT Pharmacometrics Syst Pharmacol
, vol.3
, pp. e139
-
-
Sharan, S.1
Woo, S.2
-
50
-
-
84926486270
-
Systems pharmacology approaches for optimization of antiangiogenic therapies: challenges and opportunities
-
[50] Sharan, S., Woo, S., Systems pharmacology approaches for optimization of antiangiogenic therapies: challenges and opportunities. Front Pharmacol, 6, 2015, 33, 10.3389/fphar.2015.00033.
-
(2015)
Front Pharmacol
, vol.6
, pp. 33
-
-
Sharan, S.1
Woo, S.2
-
51
-
-
84942500668
-
Mechanism-based mathematical modeling of combined gemcitabine and birinapant in pancreatic cancer cells
-
[51] Zhu, X., Straubinger, R.M., Jusko, W.J., Mechanism-based mathematical modeling of combined gemcitabine and birinapant in pancreatic cancer cells. J Pharmacokinet Pharmacodyn 42:5 (2015), 477–496, 10.1007/s10928-015-9429-x.
-
(2015)
J Pharmacokinet Pharmacodyn
, vol.42
, Issue.5
, pp. 477-496
-
-
Zhu, X.1
Straubinger, R.M.2
Jusko, W.J.3
-
52
-
-
84991617056
-
Tetralogic pharmaceuticals, dose escalation, combination chemotherapy safety study of birinapant (TL32711), in subjects with advanced or metastatic solid tumors
-
– [cited 2016 April 18], Bethesda (MD): National Library of Medicine (US) Available from NLM Identifier:
-
[52] Tetralogic pharmaceuticals, dose escalation, combination chemotherapy safety study of birinapant (TL32711), in subjects with advanced or metastatic solid tumors. ClinicalTrials.gov [Internet], 2010 - [cited 2016 April 18], Bethesda (MD): National Library of Medicine (US) Available from https://clinicaltrial s.gov/ct2/show/NCT01188499 NLM Identifier: NCT01188499.
-
(2010)
ClinicalTrials.gov [Internet]
-
-
-
53
-
-
84875456220
-
Has the time come for predictive computer modeling in CNS drug discovery and development?
-
[53] Geerts, H., Spiros, A., Roberts, P., Carr, R., Has the time come for predictive computer modeling in CNS drug discovery and development?. CPT: Pharmacometrics & Syst Pharmacol, 1(11), 2012, e16, 10.1038/psp.2012.17.
-
(2012)
CPT: Pharmacometrics & Syst Pharmacol
, vol.1
, Issue.11
, pp. e16
-
-
Geerts, H.1
Spiros, A.2
Roberts, P.3
Carr, R.4
-
54
-
-
84904752371
-
Successful therapies for Alzheimer's disease: why so many in animal models and none in humans?
-
[54] Franco, R., Cedazo-Minguez, A., Successful therapies for Alzheimer's disease: why so many in animal models and none in humans?. Front Pharmacol, 5, 2014, 146, 10.3389/fphar.2014.00146.
-
(2014)
Front Pharmacol
, vol.5
, pp. 146
-
-
Franco, R.1
Cedazo-Minguez, A.2
-
55
-
-
70350338847
-
Of mice and men
-
[55] Geerts, H., Of mice and men. CNS Drugs 23:11 (2009), 915–926, 10.2165/11310890-000000000-00000.
-
(2009)
CNS Drugs
, vol.23
, Issue.11
, pp. 915-926
-
-
Geerts, H.1
-
56
-
-
84908690617
-
Systems pharmacology modeling in neuroscience: prediction and outcome of PF-04995274, a 5-HT4 partial agonist, in a clinical scopolamine impairment trial
-
[56] Nicholas, T., Duvvuri, S., Leurent, C., Raunig, D., Rapp, T., Systems pharmacology modeling in neuroscience: prediction and outcome of PF-04995274, a 5-HT4 partial agonist, in a clinical scopolamine impairment trial. Adv in Alzheimer's Dis 02:03 (2013), 83–98, 10.4236/aad.2013.23012.
-
(2013)
Adv in Alzheimer's Dis
, vol.2
, Issue.3
, pp. 83-98
-
-
Nicholas, T.1
Duvvuri, S.2
Leurent, C.3
Raunig, D.4
Rapp, T.5
-
57
-
-
84962007152
-
A humanized clinically calibrated quantitative systems pharmacology model for hypokinetic motor symptoms in Parkinson's disease
-
[57] Roberts, P., Spiros, A., Geerts, H., A humanized clinically calibrated quantitative systems pharmacology model for hypokinetic motor symptoms in Parkinson's disease. Front Pharmacol, 7, 2016, 10.3389/fphar.2016.00006.
-
(2016)
Front Pharmacol
, vol.7
-
-
Roberts, P.1
Spiros, A.2
Geerts, H.3
-
58
-
-
79251648963
-
Computational models reduce complexity and accelerate insight into cardiac signaling networks
-
[58] Yang, J.H., Saucerman, J.J., Computational models reduce complexity and accelerate insight into cardiac signaling networks. Circ Res 108:1 (2011), 85–97, 10.1161/circresaha.110.223602.
-
(2011)
Circ Res
, vol.108
, Issue.1
, pp. 85-97
-
-
Yang, J.H.1
Saucerman, J.J.2
-
59
-
-
80052926623
-
Computational fluid dynamics in cardiovascular disease
-
[59] Lee, B.-K., Computational fluid dynamics in cardiovascular disease. Korean Circ J, 41(8), 2011, 423, 10.4070/kcj.2011.41.8.423.
-
(2011)
Korean Circ J
, vol.41
, Issue.8
, pp. 423
-
-
Lee, B.-K.1
-
60
-
-
84908569666
-
A decade of modelling drug release from arterial stents
-
[60] McGinty, S., A decade of modelling drug release from arterial stents. Math Biosci 257 (2014), 80–90, 10.1016/j.mbs.2014.06.016.
-
(2014)
Math Biosci
, vol.257
, pp. 80-90
-
-
McGinty, S.1
-
61
-
-
84962071084
-
Systems pharmacology and rational polypharmacy: nitric oxide-cyclic GMP signaling pathway as an illustrative example and derivation of the general case
-
[61] Garmaroudi, F.S., Handy, D.E., Liu, Y.-Y., Loscalzo, J., Systems pharmacology and rational polypharmacy: nitric oxide-cyclic GMP signaling pathway as an illustrative example and derivation of the general case. PLOS Comput Biol, 12(3), 2016, e1004822, 10.1371/journal.pcbi.1004822.
-
(2016)
PLOS Comput Biol
, vol.12
, Issue.3
, pp. e1004822
-
-
Garmaroudi, F.S.1
Handy, D.E.2
Liu, Y.-Y.3
Loscalzo, J.4
-
62
-
-
84959289711
-
Recent developments in using mechanistic cardiac modelling for drug safety evaluation
-
In Press
-
[62] Davies, M.R., Wang, K., Mirams, G.R., Caruso, A., Noble, D., Recent developments in using mechanistic cardiac modelling for drug safety evaluation. Drug Discov Today, 2016, 10.1016/j.drudis.2016.02.003 In Press.
-
(2016)
Drug Discov Today
-
-
Davies, M.R.1
Wang, K.2
Mirams, G.R.3
Caruso, A.4
Noble, D.5
-
63
-
-
84906859136
-
Interaction between domperidone and ketoconazole: toward prediction of consequent QTc prolongation using purely in vitro information
-
[63] Mishra, H., Polak, S., Jamei, M., Rostami-Hodjegan, A., Interaction between domperidone and ketoconazole: toward prediction of consequent QTc prolongation using purely in vitro information. CPT Pharmacometrics Syst Pharmacol, 3(8), 2014, e130, 10.1038/psp.2014.26.
-
(2014)
CPT Pharmacometrics Syst Pharmacol
, vol.3
, Issue.8
, pp. e130
-
-
Mishra, H.1
Polak, S.2
Jamei, M.3
Rostami-Hodjegan, A.4
-
64
-
-
33747620519
-
Systems biology and combination therapy in the quest for clinical efficacy
-
[64] Fitzgerald, J.B., Schoeberl, B., Nielsen, U.B., Sorger, P.K., Systems biology and combination therapy in the quest for clinical efficacy. Nat Chem Biol 2:9 (2006), 458–466, 10.1038/nchembio817.
-
(2006)
Nat Chem Biol
, vol.2
, Issue.9
, pp. 458-466
-
-
Fitzgerald, J.B.1
Schoeberl, B.2
Nielsen, U.B.3
Sorger, P.K.4
-
65
-
-
84903772139
-
Effects of IL-1β-blocking therapies in type 2 diabetes mellitus: a quantitative systems pharmacology modeling approach to explore underlying mechanisms
-
[65] Palmér, R., Nyman, E., Penney, M., Marley, A., Cedersund, G., Agoram, B., Effects of IL-1β-blocking therapies in type 2 diabetes mellitus: a quantitative systems pharmacology modeling approach to explore underlying mechanisms. CPT Pharmacometrics Syst Pharmacol, 3(6), 2014, e118, 10.1038/psp.2014.16.
-
(2014)
CPT Pharmacometrics Syst Pharmacol
, vol.3
, Issue.6
, pp. e118
-
-
Palmér, R.1
Nyman, E.2
Penney, M.3
Marley, A.4
Cedersund, G.5
Agoram, B.6
-
66
-
-
84884623483
-
The development of a fully-integrated immune response model (FIRM) simulator of the immune response through integration of multiple subset models
-
[66] Palsson, S., Hickling, T.P., Bradshaw-Pierce, E.L., Zager, M., Jooss, K., The development of a fully-integrated immune response model (FIRM) simulator of the immune response through integration of multiple subset models. BMC Syst Biol, 7, 2013, 95, 10.1186/1752-0509-7-95.
-
(2013)
BMC Syst Biol
, vol.7
, pp. 95
-
-
Palsson, S.1
Hickling, T.P.2
Bradshaw-Pierce, E.L.3
Zager, M.4
Jooss, K.5
-
67
-
-
84885115975
-
Systems pharmacology models can be used to understand complex pharmacokinetic-pharmacodynamic behavior: an example using 5-lipoxygenase inhibitors
-
[67] Demin, O., Karelina, T., Svetlichniy, D., Metelkin, E., Speshilov, G., Systems pharmacology models can be used to understand complex pharmacokinetic-pharmacodynamic behavior: an example using 5-lipoxygenase inhibitors. CPT Pharmacometrics Syst Pharmacol, 2, 2013, e74, 10.1038/psp.2013.49.
-
(2013)
CPT Pharmacometrics Syst Pharmacol
, vol.2
, pp. e74
-
-
Demin, O.1
Karelina, T.2
Svetlichniy, D.3
Metelkin, E.4
Speshilov, G.5
-
68
-
-
84894148547
-
Computational models reveal a passive mechanism for cell migration in the crypt
-
[68] Dunn, S.-J., Näthke, I.S., Osborne, J.M., Computational models reveal a passive mechanism for cell migration in the crypt. PloS ONE, 8(11), 2013, e80516, 10.1371/journal.pone.0080516.
-
(2013)
PloS ONE
, vol.8
, Issue.11
, pp. e80516
-
-
Dunn, S.-J.1
Näthke, I.S.2
Osborne, J.M.3
-
69
-
-
84942254105
-
Systems modeling of interactions between mucosal immunity and the gut microbiome during clostridium difficile infection
-
[69] Leber, A., Viladomiu, M., Hontecillas, R., Abedi, V., Philipson, C., Hoops, S., Systems modeling of interactions between mucosal immunity and the gut microbiome during clostridium difficile infection. PLOS ONE, 10(7), 2015, e0134849, 10.1371/journal.pone.0134849.
-
(2015)
PLOS ONE
, vol.10
, Issue.7
, pp. e0134849
-
-
Leber, A.1
Viladomiu, M.2
Hontecillas, R.3
Abedi, V.4
Philipson, C.5
Hoops, S.6
-
70
-
-
81355123249
-
Software for systems biology: from tools to integrated platforms
-
[70] Ghosh, S., Matsuoka, Y., Asai, Y., Hsin, K.-Y., Kitano, H., Software for systems biology: from tools to integrated platforms. Nat Rev Genet, 2011, 10.1038/nrg3096.
-
(2011)
Nat Rev Genet
-
-
Ghosh, S.1
Matsuoka, Y.2
Asai, Y.3
Hsin, K.-Y.4
Kitano, H.5
-
71
-
-
84890553923
-
Toward an integrated software platform for systems pharmacology
-
[71] Ghosh, S., Matsuoka, Y., Asai, Y., Hsin, K.-Y., Kitano, H., Toward an integrated software platform for systems pharmacology. Biopharm Drug Dispos 34:9 (2013), 508–526, 10.1002/bdd.1875.
-
(2013)
Biopharm Drug Dispos
, vol.34
, Issue.9
, pp. 508-526
-
-
Ghosh, S.1
Matsuoka, Y.2
Asai, Y.3
Hsin, K.-Y.4
Kitano, H.5
-
72
-
-
0033982936
-
KEGG: kyoto encyclopedia of genes and genomes
-
[72] Kanehisa, M., Goto, S., KEGG: kyoto encyclopedia of genes and genomes. Nucleic Acids Res 28:1 (2000), 27–30, 10.1093/nar/28.1.27.
-
(2000)
Nucleic Acids Res
, vol.28
, Issue.1
, pp. 27-30
-
-
Kanehisa, M.1
Goto, S.2
-
73
-
-
13444259844
-
Reactome: a knowledgebase of biological pathways
-
[73] Joshi-Tope, G., Reactome: a knowledgebase of biological pathways. Nucleic Acids Res 33:Database issue (2004), D428–D432, 10.1093/nar/gki072.
-
(2004)
Nucleic Acids Res
, vol.33
, Issue.Database issue
, pp. D428-D432
-
-
Joshi-Tope, G.1
-
74
-
-
0242490780
-
Cytoscape: a software environment for integrated models of biomolecular interaction networks
-
[74] Shannon, P., Cytoscape: a software environment for integrated models of biomolecular interaction networks. Genome Res 13:11 (2003), 2498–2504, 10.1101/gr.1239303.
-
(2003)
Genome Res
, vol.13
, Issue.11
, pp. 2498-2504
-
-
Shannon, P.1
-
75
-
-
9444266171
-
CellDesigner: a process diagram editor for gene-regulatory and biochemical networks
-
[75] Funahashi, A., Morohashi, M., Kitano, H., Tanimura, N., CellDesigner: a process diagram editor for gene-regulatory and biochemical networks. BIOSILICO, 1:5 (2003), 159–162, 10.1016/s1478-5382(03)02370-9.
-
(2003)
BIOSILICO
, vol.1
, Issue.5
, pp. 159-162
-
-
Funahashi, A.1
Morohashi, M.2
Kitano, H.3
Tanimura, N.4
-
76
-
-
33845368513
-
COPASI-a COmplex PAthway SImulator
-
[76] Hoops, S., Sahle, S., Gauges, R., Lee, C., Pahle, J., Simus, N., COPASI-a COmplex PAthway SImulator. Bioinformatics 22:24 (2006), 3067–3074, 10.1093/bioinformatics/btl485.
-
(2006)
Bioinformatics
, vol.22
, Issue.24
, pp. 3067-3074
-
-
Hoops, S.1
Sahle, S.2
Gauges, R.3
Lee, C.4
Pahle, J.5
Simus, N.6
-
77
-
-
84961153928
-
R: a language and environment for statistical computing
-
Vienna, Austria
-
[77] Core Team, R., R: a language and environment for statistical computing. R foundation for statistical computing, 2016, Vienna, Austria https://www.R-project.org/.
-
(2016)
R foundation for statistical computing
-
-
Core Team, R.1
-
78
-
-
84903301980
-
GNU octave version 4.0.0 manual: a high-level interactive language for numerical computations
-
[78] Eaton, J.W., Bateman, D., Hauberg, S., Wehbring, R., GNU octave version 4.0.0 manual: a high-level interactive language for numerical computations. 2015 http://www.gnu.org/software/octave/doc/interpreter.
-
(2015)
-
-
Eaton, J.W.1
Bateman, D.2
Hauberg, S.3
Wehbring, R.4
-
79
-
-
84991669270
-
-
The MathWorks, Inc. Natick, Massachusetts, United States
-
[79] MATLAB and Simulink product families., 2016, The MathWorks, Inc., Natick, Massachusetts, United States.
-
(2016)
-
-
-
80
-
-
67649131017
-
The simcyp ® population-based ADME simulator
-
[80] Jamei, M., Marciniak, S., Feng, K., Barnett, A., Tucker, G., Rostami-Hodjegan, A., The simcyp ® population-based ADME simulator. Expert Opin Drug Metab Toxicol 5:2 (2009), 211–223, 10.1517/17425250802691074.
-
(2009)
Expert Opin Drug Metab Toxicol
, vol.5
, Issue.2
, pp. 211-223
-
-
Jamei, M.1
Marciniak, S.2
Feng, K.3
Barnett, A.4
Tucker, G.5
Rostami-Hodjegan, A.6
-
81
-
-
84936944588
-
Editorial: the emerging discipline of quantitative systems pharmacology
-
[81] Leil, T.A., Ermakov, S., Editorial: the emerging discipline of quantitative systems pharmacology. Front Pharmacol, 6, 2015, 129, 10.3389/fphar.2015.00129.
-
(2015)
Front Pharmacol
, vol.6
, pp. 129
-
-
Leil, T.A.1
Ermakov, S.2
-
82
-
-
0037342537
-
The systems biology markup language (SBML): a medium for representation and exchange of biochemical network models
-
[82] Hucka, M., Finney, A., Sauro, H.M., Bolouri, H., Doyle, J.C., The systems biology markup language (SBML): a medium for representation and exchange of biochemical network models. Bioinformatics 19:4 (2003), 524–531, 10.1093/bioinformatics/btg015.
-
(2003)
Bioinformatics
, vol.19
, Issue.4
, pp. 524-531
-
-
Hucka, M.1
Finney, A.2
Sauro, H.M.3
Bolouri, H.4
Doyle, J.C.5
-
83
-
-
84936749645
-
Pharmacometrics markup language (PharmML): opening new perspectives for model exchange in drug development
-
[83] Swat, M.J., Moodie, S., Wimalaratne, S.M., Kristensen, N.R., Lavielle, M., Pharmacometrics markup language (PharmML): opening new perspectives for model exchange in drug development. CPT Pharmacometrics Syst Pharmacol 4:6 (2015), 316–319, 10.1002/psp4.57.
-
(2015)
CPT Pharmacometrics Syst Pharmacol
, vol.4
, Issue.6
, pp. 316-319
-
-
Swat, M.J.1
Moodie, S.2
Wimalaratne, S.M.3
Kristensen, N.R.4
Lavielle, M.5
-
84
-
-
84881185232
-
Drug and disease model resources: a consortium to create standards and tools to enhance model-based drug development
-
[84] Harnisch, L., Matthews, I., Chard, J., Karlsson, M., Drug and disease model resources: a consortium to create standards and tools to enhance model-based drug development. CPT Pharmacometrics Syst Pharmacol, 2, 2013, e34, 10.1038/psp.2013.10.
-
(2013)
CPT Pharmacometrics Syst Pharmacol
, vol.2
, pp. e34
-
-
Harnisch, L.1
Matthews, I.2
Chard, J.3
Karlsson, M.4
-
85
-
-
79953249834
-
High drug attrition rates—where are we going wrong?
-
[85] Hutchinson, L., Kirk, R., High drug attrition rates—where are we going wrong?. Nat Rev Clin Oncol 8:4 (2011), 189–190, 10.1038/nrclinonc.2011.34.
-
(2011)
Nat Rev Clin Oncol
, vol.8
, Issue.4
, pp. 189-190
-
-
Hutchinson, L.1
Kirk, R.2
-
86
-
-
84863523396
-
Relevance of systems pharmacology in drug discovery
-
[86] Cucurull-Sanchez, L., Spink, K.G., Moschos, S.A., Relevance of systems pharmacology in drug discovery. Drug Discov Today 17:13-14 (2012), 665–670, 10.1016/j.drudis.2012.01.015.
-
(2012)
Drug Discov Today
, vol.17
, Issue.13-14
, pp. 665-670
-
-
Cucurull-Sanchez, L.1
Spink, K.G.2
Moschos, S.A.3
-
87
-
-
84911861772
-
The rise of systems pharmacology in drug discovery and development
-
[87] Benson, N., van der Graaf, P.H., The rise of systems pharmacology in drug discovery and development. Future Med Chem 6:16 (2014), 1731–1734, 10.4155/fmc.14.66.
-
(2014)
Future Med Chem
, vol.6
, Issue.16
, pp. 1731-1734
-
-
Benson, N.1
van der Graaf, P.H.2
-
88
-
-
84926673199
-
Quantitative systems pharmacology can reduce attrition and improve productivity in pharmaceutical research and development
-
[88] Leil, T.A., Bertz, R., Quantitative systems pharmacology can reduce attrition and improve productivity in pharmaceutical research and development. Front Pharmacol, 5, 2014, 10.3389/fphar.2014.00247.
-
(2014)
Front Pharmacol
, vol.5
-
-
Leil, T.A.1
Bertz, R.2
-
89
-
-
84876567464
-
Systems pharmacology for drug discovery and development: paradigm shift or flash in the pan?
-
[89] Vicini, P., van der Graaf, P.H., Systems pharmacology for drug discovery and development: paradigm shift or flash in the pan?. Clin Pharmacol Ther 93:5 (2013), 379–381, 10.1038/clpt.2013.40.
-
(2013)
Clin Pharmacol Ther
, vol.93
, Issue.5
, pp. 379-381
-
-
Vicini, P.1
van der Graaf, P.H.2
|