Skip to main content
SpringerLink
Log in

Data standards for model-informed drug development: an ISoP initiative

  • Perspective
  • Published:
Journal of Pharmacokinetics and Pharmacodynamics Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Grasela T, Fiedler-Kelly J, Hitchcock D (2009) Improving the efficiency and ensuring the quality of data assembly for pharmacometric analysis. PAGE 18 Abstr 1552. www.page-meeting.org/?abstract=1552

  2. European Medicines Agency policy on publication of clinical data for medicinal products for human use. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf

  3. Wilkins JJ, Jonsson EN (2013) Reproducible pharmacometrics [tutorial]. PAGE 22 Abstr 2774. www.page-meeting.org/?abstract=2774

  4. Marshall SF et al (2016) Good practices in model-informed drug discovery and development: practice, application, and documentation. CPT Pharmacomet Syst Pharmacol 5(3):93–122

    Article  CAS  Google Scholar 

  5. Harnisch L, Matthews I, Chard J, Karlsson MO (2013) Drug and disease model resources: a consortium to create standards and tools to enhance model-based drug development. CPT Pharmacomet Syst Pharmacol 2:e34

    Article  CAS  Google Scholar 

  6. Woosley RL, Myers RT, Goodsaid F (2010) The critical path institute’s approach to precompetitive sharing and advancing regulatory science. Clin Pharmacol Ther 87(5):530–533

    Article  CAS  PubMed  Google Scholar 

  7. Romero K et al (2010) Pharmacometrics as a discipline is entering the “industrialization” phase: standards, automation, knowledge sharing, and training are critical for future success. J Clin Pharmacol 50(9 Suppl):9S–19S

    Article  PubMed  Google Scholar 

  8. Karlsson MO, Conrado D, Romero K, Sarr C, Wilkins JJ (2017) Open innovation: towards sharing of data, models and workflows. Eur J Pharm Sci 109S:S65–S71

    PubMed  Google Scholar 

  9. Radivojevic A, Schmidt H (2015) Datasets for pharmacometric analyses: internal review and standardization efforts. J Pharmacokinet Pharmacodyn 42:S81–S82

    Google Scholar 

  10. Thanneer N, Roy A (2014) Best practices for preparation of pharmacometric analysis data sets. ACoP5. http://www.acop7.org/assets/Legacy_ACOPs/ACOP5/Poster_Abstracts/m-058.pdf

Download references

Acknowledgements

The authors thank and acknowledge the contributions of ISoP Data Standards initiative group members: Ted Grasela, Jeffry Florian, Timothy Bergsma, Warwick Benger, Christian Rasmussen, Henning Schmidt, Liping Zhang, Scott Pivirotto, Stuart Pearce, Pragathi Kotha Venkata, Vishak Subramoney and Ana Henry, as well as René Bruno for his feedback on the manuscript.

Author information

Authors and Affiliations

  1. Pharmacometrics, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

    Andrijana Radivojevic

  2. Pfizer Global Research, Groton, CT, USA

    Brian Corrigan

  3. Bayer AG, Berlin, Germany

    Nicholas Downie

  4. AstraZeneca, Waltham, MA, USA

    Robert Fox & Huan Liu

  5. Cognigen Corporation, Buffalo, NY, USA

    Jill Fiedler-Kelly

  6. Amgen, Thousand Oaks, CA, USA

    Murad Melhem

  7. Eli Lilly and Company, Indianapolis, IN, USA

    David Radke

  8. VCA-Plus, Raleigh, NC, USA

    Peter Schaefer

  9. Merck & Co., Kenilworth, NJ, USA

    Jing Su

  10. Simcyp (A Certara Company), Sheffield, UK

    Maciej J. Swat

  11. Certara, Princeton, NJ, USA

    Nathan S. Teuscher

  12. Bristol-Myers Squibb, Princeton, NJ, USA

    Neelima Thanneer

  13. Janssen, Horsham, PA, USA

    Alice Zong

  14. Occams, Amstelveen, The Netherlands

    Justin J. Wilkins

Authors
  1. Andrijana Radivojevic
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Brian Corrigan
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Nicholas Downie
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Robert Fox
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jill Fiedler-Kelly
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Huan Liu
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Murad Melhem
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. David Radke
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Peter Schaefer
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Jing Su
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Maciej J. Swat
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Nathan S. Teuscher
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Neelima Thanneer
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Alice Zong
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Justin J. Wilkins
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Andrijana Radivojevic.

Ethics declarations

Conflict of interest

A.R. is an employee of IntiGrowth LLC, B.C. of Pfizer Global Research, N.D. of Bayer AG, R.F. and H.L. of AstraZeneca, J.F.-K. of Cognigen Corporation (a SimulationsPlus company), M.M. of Amgen Inc., D.R. of Eli Lilly and Company, P.S. of VCA-Plus, J.S. of Merck, M.J.S. of Simcyp (a Certara company), N.S.T. of Certara, N.T. of Bristol-Myers Squibb, A.Z. of Janssen Pharmaceutical Companies of Johnson & Johnson, J.J.W. of Occams.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Radivojevic, A., Corrigan, B., Downie, N. et al. Data standards for model-informed drug development: an ISoP initiative. J Pharmacokinet Pharmacodyn 45, 659–661 (2018). https://doi.org/10.1007/s10928-018-9595-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10928-018-9595-8

Keywords

Search

Navigation