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Development: Pharmacokinetics—Systems Biology in Health and Disease III

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Systems Biology in Biotech & Pharma

Part of the book series: SpringerBriefs in Pharmaceutical Science & Drug Development ((BRIEFSPSDD,volume 2))

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Abstract

In silico PKPD/ADMET and biochemical-mechanistic methods will become a standard approach in the coming few years via the employment of BI and SB tools at the multiscale whole-body level. So far, the overall impact of toxicity markers on preclinical safety testing has been modest. The greatest benefit of PBPK models is they may allow for individualized health care.

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References

  1. Lappin G, Garner RC (2008) The utility of microdosing over the past 5 years. Expert Opin Drug Metab Toxicol 4(12):1499–1506

    Article  PubMed  CAS  Google Scholar 

  2. Buchan P (2007) Smarter candidate selectionutilizing microdosing in exploratory clinical studies. Ernst Schering Res Found Workshop (59):7–27

    Google Scholar 

  3. Stumpf WE (2006) The dose makes the medicine. Drug Dis Today 11(11-12):550–555

    Google Scholar 

  4. Shen LZ, Coffey T, Deng W (2008) A Bayesian approach to utilizing prior data in new drug development. J Biopharm Stat 18(2):227–243

    Article  PubMed  Google Scholar 

  5. Chow SC, Chang M (2008) Adaptive design methods in clinical trials—a review. Orphanet J Rare Dis 2(3):11

    Article  Google Scholar 

  6. Simon R (2008) The use of genomics in clinical trial design. Clin Cancer Res 14(19):5984–5993

    Article  PubMed  Google Scholar 

  7. Hozo I, Djulbegovic B, Clark O, Lyman GH (2005) Use of re-randomized data in meta-analysis. BMC Medical Res Methodol 5:17

    Article  Google Scholar 

  8. Freidlin B, Simon R (2005) Evaluation of randomized discontinuation design. JCO 23:5094–5098

    Article  Google Scholar 

  9. Halla DB, Meierb U, Dienerc H-C (2005) A group sequential adaptive treatment assignment design for proof of concept and dose selection in headache trials. Contemp Clin Trials 26:349–364

    Article  Google Scholar 

  10. Copeland RA, Pompliano DL, Meek TD (2006) Drug-target residence time and its implications for lead optimization. Nat Rev Drug Discov 5(9):730–739 Erratum in: Nat Rev Drug Discov (2007) 6(3):249

    Article  PubMed  CAS  Google Scholar 

  11. Ohlson S (2008) Designing transient binding drugs: a new concept for drug discovery. Drug Discov Today 13(9–10):433–439

    Article  PubMed  CAS  Google Scholar 

  12. Kuhlmann J, Wensing G (2006) The applications of biomarkers in early clinical drug development to improve decision-making processes. Curr Clin Pharmacol 1(2):185–191

    Article  PubMed  CAS  Google Scholar 

  13. Danhof M, Alvan G, Dahl SG, Kuhlmann J, Paintaud G (2005) Mechanism-based pharmacokinetic–pharmacodynamic modeling—A new classification of biomarkers. Pharm Res 22( 9):1432–1437

    Google Scholar 

  14. Guillouzo A, Guguen-Guillouzo C (2008) Evolving concepts in liver tissue modeling and implications for in vitro toxicology. Expert Opin Drug Metab Toxicol 4(10):1279–1294

    Article  PubMed  CAS  Google Scholar 

  15. Stevens JL (2006) Future of toxicologymechanisms of toxicity and drug safety: where do we go from here? Chem Res Toxicol 19(11):1393–1401

    Article  PubMed  CAS  Google Scholar 

  16. Mohan CG, Gandhi T, Garg D, Shinde R (2007) Computer-assisted methods in chemical toxicity prediction. Mini Rev Med Chem 7(5):499–507

    Article  PubMed  CAS  Google Scholar 

  17. Wierling C, Herwig R, Lehrach H (2007) Resources, standards and tools for systems biology. Brief Funct Genomic Proteomic 6(3):240–251

    Article  PubMed  CAS  Google Scholar 

  18. Muster W, Breidenbach A, Fischer H, Kirchner S, Müller L, Pähler A (2008) Computational toxicology in drug development. Drug Discov Today 13(7–8):303–310

    Article  PubMed  CAS  Google Scholar 

  19. Judson R, Elloumi F, Setzer RW, Li Z, Shah I (2008) A comparison of machine learning algorithms for chemical toxicity classification using a simulated multi-scale data model. BMC Bioinformatics 9:241

    Article  PubMed  Google Scholar 

  20. Jenwitheesuk E, Horst JA, Rivas KL, Van Voorhis WC, Samudrala R (2008) Novel paradigms for drug discovery: computational multitarget screening. Trends Pharmacol Sci 29(2):62–71

    Article  PubMed  CAS  Google Scholar 

  21. Schmitt W, Willmann S (2004) Physiology-based pharmacokinetic modeling: ready to be used. Drug Discov Today Technol 1(4):449–456

    Article  Google Scholar 

  22. Edginton AN, Theil FP, Schmitt W, Willmann S (2008) Whole body physiologically-based pharmacokinetic models: their use in clinical drug development. Expert Opin Drug Metab Toxicol 4(9):1143–1152

    Article  PubMed  CAS  Google Scholar 

  23. Barton HA (2005) Computational pharmacokinetics during developmental windows of susceptibility. J Toxicol Environ Health A 68(11–12):889–900

    Article  PubMed  CAS  Google Scholar 

  24. Nestorov I (2007) Whole-body physiologically based pharmacokinetic models. Expert Opin Drug Metab Toxicol 3(2):235–249

    Article  PubMed  CAS  Google Scholar 

  25. Hopkins AL (2008) Network pharmacology: the next paradigm in drug discovery. Nat Chem Biol 4(11):682–690

    Article  PubMed  CAS  Google Scholar 

Download references

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Correspondence to Aleš Prokop .

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Prokop, A., Michelson, S. (2012). Development: Pharmacokinetics—Systems Biology in Health and Disease III. In: Systems Biology in Biotech & Pharma. SpringerBriefs in Pharmaceutical Science & Drug Development, vol 2. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2849-3_7

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  • DOI: https://doi.org/10.1007/978-94-007-2849-3_7

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  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-007-2848-6

  • Online ISBN: 978-94-007-2849-3

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