Systems pharmacology to predict drug safety in drug development

European Journal of Pharmaceutical Sciences

Volumn 94, Issue , 2016, Pages 93-95

  Trame, Mirjam N ^a   Biliouris, Konstantinos ^a   Lesko, Lawrence J ^a   Mettetal, Jerome T ^b  

^a UNIVERSITY OF FLORIDA   (United States)

^b ASTRAZENECA   (United Kingdom)

Author keywords

Adverse drug events; Drug development; Drug safety; Systems pharmacology

Indexed keywords

ANTINEOPLASTIC AGENT; BIOLOGICAL PRODUCT; MONOCLONAL ANTIBODY; PROTEIN TYROSINE KINASE INHIBITOR;

ADVERSE DRUG REACTION; ARTICLE; BIOMEDICINE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG INTERACTION; DRUG RESEARCH; DRUG SAFETY; DRUG SYNTHESIS; DRUG TARGETING; FOOD AND DRUG ADMINISTRATION; HEART DISEASE; ONCOLOGY; PHARMACODYNAMICS; PHARMACOKINETICS; PHARMACOLOGY; PREDICTION; PRIORITY JOURNAL; QUANTITATIVE STUDY; RARE DISEASE; RISK BENEFIT ANALYSIS; RISK REDUCTION; SYSTEMS PHARMACOLOGY; TOXIC HEPATITIS; ANIMAL; CLINICAL PHARMACOLOGY; DRUG DEVELOPMENT; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FORECASTING; HUMAN; PROCEDURES; SYSTEMS BIOLOGY; TRENDS;

ANIMALS; DRUG DISCOVERY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FORECASTING; HUMANS; PHARMACOLOGY, CLINICAL; SYSTEMS BIOLOGY;

EID: 84971641358     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2016.05.027     Document Type: Article

References (30)

1. Abernethy, D.R., Woodcock, J., Lesko, L.J., Pharmacological mechanism-based drug safety assessment and prediction. Clin. Pharmacol. Ther. 89:6 (2011), 793–797 (Jun).
2. Bai, J.P.F., Abernethy, D.R., Systems pharmacology to predict drug toxicity: integration across levels of biological organization. Annu. Rev. Pharmacol. Toxicol. 53 (2013), 451–473.
3. Berger, S.I., Ma'ayan, A., Iyengar, R., Systems pharmacology of arrhythmias. Sci. Signal., 3(118), 2010, ra30.
4. Biliouris, K., Lavielle, M., Trame, M.N., MatVPC: a user-friendly MATLAB-based tool for the simulation and evaluation of systems pharmacology models. CPT Pharmacometrics Syst. Pharmacol. 4:9 (2015), 547–557 (Sep).
5. Bowes, J., Brown, A.J., Hamon, J., Jarolimek, W., Sridhar, A., Waldron, G., et al. Reducing safety-related drug attrition: the use of in vitro pharmacological profiling. Nat. Rev. Drug Discov. 11:12 (2012), 909–922 (Dec).
6. Dal Pan, G.J., Arlett, P., The role of pharmacoepidemiology in regulatory agencies. Pharmacoepidemiology, fifth ed., 2011, 107–116.
7. Gintant, G., Sager, P.T., Stockbridge, N., Evolution of strategies to improve preclinical cardiac safety testing. Nat. Rev. Drug Discov., 2016 (Feb 19).
8. Glinka, A., Polak, S., The effects of six antipsychotic agents on QTc–an attempt to mimic clinical trial through simulation including variability in the population. Comput. Biol. Med. 47 (2014), 20–26 (Apr).
9. Goodsaid, F.M., Frueh, F.W., Mattes, W., The predictive safety testing consortium: a synthesis of the goals, challenges and accomplishments of the critical path. Drug Discov. Today Technol. 4:2 (2007), 47–50.
10. 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 (Jan).
11. Lesko, L.J., Zheng, S., Schmidt, S., Systems approaches in risk assessment. Clin. Pharmacol. Ther. 93:5 (2013), 413–424 (May).
12. Li, P., Huang, C., Fu, Y., Wang, J., Wu, Z., Ru, J., et al. Large-scale exploration and analysis of drug combinations. Bioinformatics (Oxford, England) 31:12 (2015), 2007–2016 (Jun 15).
13. Liebler, D.C., Guengerich, F.P., Elucidating mechanisms of drug-induced toxicity. Nat. Rev. Drug Discov. 4:5 (2005), 410–420 (May).
14. Mirams, G.R., Cui, Y., Sher, A., Fink, M., Cooper, J., Heath, B.M., et al. Simulation of multiple ion channel block provides improved early prediction of compounds' clinical torsadogenic risk. Cardiovasc. Res. 91:1 (2011), 53–61 (Jul 1).
15. Munos, B., Lessons from 60 years of pharmaceutical innovation. Nat. Rev. Drug Discov. 8:12 (2009), 959–968 (Dec).
16. Peterson, M.C., Riggs, M.M., Predicting nonlinear changes in bone mineral density over time using a multiscale systems pharmacology model. CPT Pharmacometrics Syst. Pharmacol., 1, 2012, e14.
17. 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 (Mar).
18. preDiCT project description [Internet]. [cited 2016 Apr 4]. Available from: http://consortiapedia.fastercures.org/consortia/predict/.
19. predicTox project website [Internet]. [cited 2016 Apr 4]. Available from: http://www.reaganudall.org/our-work/improving-regulatory-science-processes/systems-tox-project/.
20. Rodriguez, B., Burrage, K., Gavaghan, D., Grau, V., Kohl, P., Noble, D., The systems biology approach to drug development: application to toxicity assessment of cardiac drugs. Clin. Pharmacol. Ther. 88:1 (2010), 130–134 (Jul).
21. Shoda, L.K.M., Woodhead, J.L., Siler, S.Q., Watkins, P.B., Howell, B.A., Linking physiology to toxicity using DILIsym®, a mechanistic mathematical model of drug-induced liver injury. Biopharm. Drug Dispos. 35:1 (2014), 33–49 (Jan).
22. Shon, J., Abernethy, D.R., Application of systems pharmacology to explore mechanisms of hepatotoxicity. Clin. Pharmacol. Ther. 96:5 (2014), 536–537 (Nov).
23. Slørdal, L., Spigset, O., Heart failure induced by non-cardiac drugs. Drug Saf. 29:7 (2006), 567–586.
24. Sorger, P.K., et al. 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.
25. Sorger, P.K., et al. Quantitative and Systems Pharmacology in the Post-Genomic Era: New Approaches to Discovering Drugs and Understanding Therapeutic Mechanisms. 2011.
26. Stokes, C.L., Cirit, M., Lauffenburger, D.A., Physiome-on-a-Chip: the challenge of “scaling” in design, operation, and translation of Microphysiological systems. CPT Pharmacometrics Syst. Pharmacol. 4:10 (2015), 559–562 (Oct).
27. 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, 2014, e142.
28. Wermuth, C.G., Multitargeted drugs: the end of the “one-target-one-disease” philosophy?. Drug Discov. Today 9:19 (2004), 826–827 (Oct 1).
29. Zhang, X.-Y., Trame, M.N., Lesko, L.J., Schmidt, S., Sobol Sensitivity Analysis: A Tool to Guide the Development and Evaluation of Systems Pharmacology Models. 4, 2015, 69–79.
30. Zhou, X., Huntjens, D., Gilissen, R., A systems pharmacology model for predicting effects of factor Xa inhibitors in healthy subjects: assessment of pharmacokinetics and binding kinetics. CPT Pharmacometrics Syst. Pharmacol. 4:11 (2015), 650–659 (Nov).