Data standards for model-informed drug development: an ISoP initiative
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| Vydáno v: | Journal of pharmacokinetics and pharmacodynamics Ročník 45; číslo 5; s. 659 - 661 |
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| Hlavní autoři: | , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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New York
Springer US
01.10.2018
Springer Nature B.V |
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| ISSN: | 1567-567X, 1573-8744 |
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| Author | Swat, Maciej J. Corrigan, Brian Fox, Robert Liu, Huan Radivojevic, Andrijana Fiedler-Kelly, Jill Melhem, Murad Thanneer, Neelima Zong, Alice Teuscher, Nathan S. Downie, Nicholas Radke, David Su, Jing Wilkins, Justin J. Schaefer, Peter |
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| Author_xml | – sequence: 1 givenname: Andrijana orcidid: 0000-0001-6840-7366 surname: Radivojevic fullname: Radivojevic, Andrijana email: andrijana.radivojevic@intigrowth.com organization: Pharmacometrics, Novartis Pharmaceuticals Corporation – sequence: 2 givenname: Brian surname: Corrigan fullname: Corrigan, Brian organization: Pfizer Global Research – sequence: 3 givenname: Nicholas surname: Downie fullname: Downie, Nicholas organization: Bayer AG – sequence: 4 givenname: Robert surname: Fox fullname: Fox, Robert organization: AstraZeneca – sequence: 5 givenname: Jill surname: Fiedler-Kelly fullname: Fiedler-Kelly, Jill organization: Cognigen Corporation – sequence: 6 givenname: Huan surname: Liu fullname: Liu, Huan organization: AstraZeneca – sequence: 7 givenname: Murad surname: Melhem fullname: Melhem, Murad organization: Amgen – sequence: 8 givenname: David surname: Radke fullname: Radke, David organization: Eli Lilly and Company – sequence: 9 givenname: Peter surname: Schaefer fullname: Schaefer, Peter organization: VCA-Plus – sequence: 10 givenname: Jing surname: Su fullname: Su, Jing organization: Merck & Co – sequence: 11 givenname: Maciej J. surname: Swat fullname: Swat, Maciej J. organization: Simcyp (A Certara Company) – sequence: 12 givenname: Nathan S. surname: Teuscher fullname: Teuscher, Nathan S. organization: Certara – sequence: 13 givenname: Neelima surname: Thanneer fullname: Thanneer, Neelima organization: Bristol-Myers Squibb – sequence: 14 givenname: Alice surname: Zong fullname: Zong, Alice organization: Janssen – sequence: 15 givenname: Justin J. surname: Wilkins fullname: Wilkins, Justin J. organization: Occams |
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| Copyright | Springer Science+Business Media, LLC, part of Springer Nature 2018 Journal of Pharmacokinetics and Pharmacodynamics is a copyright of Springer, (2018). All Rights Reserved. |
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| DOI | 10.1007/s10928-018-9595-8 |
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| Keywords | Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) Inform Dose Selection Covers Input Data Pharmacometric Analyses |
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| References | Wilkins JJ, Jonsson EN (2013) Reproducible pharmacometrics [tutorial]. PAGE 22 Abstr 2774. www.page-meeting.org/?abstract=2774 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 RomeroKPharmacometrics as a discipline is entering the “industrialization” phase: standards, automation, knowledge sharing, and training are critical for future successJ Clin Pharmacol2010509 Suppl9S19S10.1177/009127001037778820881213 KarlssonMOConradoDRomeroKSarrCWilkinsJJOpen innovation: towards sharing of data, models and workflowsEur J Pharm Sci2017109SS65S7128684136 HarnischLMatthewsIChardJKarlssonMODrug and disease model resources: a consortium to create standards and tools to enhance model-based drug developmentCPT Pharmacomet Syst Pharmacol20132e341:CAS:528:DC%2BC3sXnvVerurg%3D10.1038/psp.2013.10 RadivojevicASchmidtHDatasets for pharmacometric analyses: internal review and standardization effortsJ Pharmacokinet Pharmacodyn201542S81S82 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 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 MarshallSFGood practices in model-informed drug discovery and development: practice, application, and documentationCPT Pharmacomet Syst Pharmacol201653931221:CAS:528:DC%2BC28XktV2nsr8%3D10.1002/psp4.12049 WoosleyRLMyersRTGoodsaidFThe critical path institute’s approach to precompetitive sharing and advancing regulatory scienceClin Pharmacol Ther20108755305331:STN:280:DC%2BC3c3nslamtA%3D%3D10.1038/clpt.2010.2720407457 |
| References_xml | – reference: Wilkins JJ, Jonsson EN (2013) Reproducible pharmacometrics [tutorial]. PAGE 22 Abstr 2774. www.page-meeting.org/?abstract=2774 – reference: HarnischLMatthewsIChardJKarlssonMODrug and disease model resources: a consortium to create standards and tools to enhance model-based drug developmentCPT Pharmacomet Syst Pharmacol20132e341:CAS:528:DC%2BC3sXnvVerurg%3D10.1038/psp.2013.10 – reference: RomeroKPharmacometrics as a discipline is entering the “industrialization” phase: standards, automation, knowledge sharing, and training are critical for future successJ Clin Pharmacol2010509 Suppl9S19S10.1177/009127001037778820881213 – reference: KarlssonMOConradoDRomeroKSarrCWilkinsJJOpen innovation: towards sharing of data, models and workflowsEur J Pharm Sci2017109SS65S7128684136 – reference: MarshallSFGood practices in model-informed drug discovery and development: practice, application, and documentationCPT Pharmacomet Syst Pharmacol201653931221:CAS:528:DC%2BC28XktV2nsr8%3D10.1002/psp4.12049 – reference: 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 – reference: 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 – reference: 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 – reference: RadivojevicASchmidtHDatasets for pharmacometric analyses: internal review and standardization effortsJ Pharmacokinet Pharmacodyn201542S81S82 – reference: WoosleyRLMyersRTGoodsaidFThe critical path institute’s approach to precompetitive sharing and advancing regulatory scienceClin Pharmacol Ther20108755305331:STN:280:DC%2BC3c3nslamtA%3D%3D10.1038/clpt.2010.2720407457 |
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| Title | Data standards for model-informed drug development: an ISoP initiative |
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