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Published bySukarno Atmadja Modified over 6 years ago
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Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies
Team members: Gretchen Dean, Leslie Lorello, Thomas Bjerregaard, Alan Brown, Kathy Brown, Christine Connolly, Jennifer Emeneggee, Anthony Fata, Joyce Ford, Wendy Freeburn, William Houser, Trina Jiao, Rihab Kordane, Christy Kubin, Ralf Loebbert,, Stephen MacMannis, Kennan March, Janessa Pierce, Anna Pron-Zwick, Jason Rogers, Susan Steen, Dennis Stocker, Michael Wasko, Joleen White
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Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies
Goals of the project To provide a recommendation for modelling of ADA data with respect to SENDIG3.0 taking into consideration SDTM approach and options in SENDIG3.1 Project status: Near Completion Ambitions and/or Accomplishments Align around a common approach for modelling of ADA data under SENDIG3.0 and prepare a poster (complete) followed by a white paper once CDISC completes modelling of ADA in SDTM. Contacts: Michael Wasko ,Thomas Bjerregaard, Gretchen Dean Link to Project WIKI
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Table 1: Proposed modelling of 12 ADA endpoints in SENDIG v3
Table 1: Proposed modelling of 12 ADA endpoints in SENDIG v3.0 using the LB domain
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