Difference between revisions of "Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies"

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== Conference Calls and Minutes ==
 
== Conference Calls and Minutes ==
Our first telecon is scheduled for Thursday April 23rd, 2015 at 2:00 PM EST.  Contact a co-lead for further details! <br /><br />
 
  
[[Investigating Endpoint Modeling - Biomarkers Minutes]]
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[[Investigating Endpoint Modeling - ADA Minutes]]
  
  
 
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Revision as of 09:43, 14 June 2017


Welcome to the site for the "Investigating Endpoint Modeling - How to Model Anti-Drug Antibody Data in Nonclinical Studies" project group.

This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on. We are part of the FDA/PhUSE Computational Sciences Nonclinical Working Group. Learn more about the larger working group at Non-Clinical Road-map and Impacts on Implementation.

Working Group Overview

Identified Need/Challenge

Project Scope

Vision

Plans

Milestones

Tasks

  • Determine endpoints
  • Call for Participants
  • Maintain wiki (ongoing)
  • Research CDISC ADA


Deliverables

Participation Needs

Call for participation!

What is the commitment?

  • Time (minimum of 1 hour every two weeks for team meetings, up to 3 hours / month)
  • Expected to contribute, not just be a spectator
  • Contribution of viewpoints and content
  • Wiki - creating/reviewing page content

If you would like to participate, please contact the co-leads for this group: Mike Wasko (michael.wasko@pdslifesciences.com) and Debra Oetzman (debra.oetzman@instem.com)

Work Group Participants

Co-leads:

  • Mike Wasko, PDS
  • Gretchen Dean, Pfizer
  • Thomas Gade Bjerregaard

Participants:


Conference Calls and Minutes

Investigating Endpoint Modeling - ADA Minutes



Last revision by Mwasko79, 2017-06-14