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

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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.

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Correspondence to Andrijana Radivojevic.

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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.

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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

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Keywords

  • Pharmacometric Analyses
  • Clinical Data Interchange Standards Consortium
  • Study Data Tabulation Model (SDTM)
  • Inform Dose Selection
  • Covers Input Data