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Project Scope |
This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents. |
| Project Leads | Email |
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Melvin Munsaka |
Nicola Newton, PHUSE Project Assistant |
Objectives & Deliverables | Timelines |
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Finalise stage 1 of draft White Paper for Public Review | Q2 2023William Palo | AbbVie
| Status |
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| colour | Blue |
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| title | Current Status |
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| Project Members | Organisation |
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| Amelia Pang | Sanofi |
| Charles Beasley | MSN |
| Darshan Bhatt | Industry |
| Eileen Navarro Almario | FDA |
| Hongli Lu | Merck |
| John Landry | Eli Lilly |
| John Marciank | AbbVie |
| Patrick Hannon | MMS |
| Paul Hayashi | A2 Healthcare Corporation |
| Preeti Venkataraman | FDA |
| Shayami | Eli Lilly |
| Swarnalatha Reddy | Industry |
| Veronical Pei Yang | FDA |
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- Complete validation and publication of Stage 1 R programs.
- Complete full draft white paper for Stage 2.
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Objectives & Deliverables | Timelines |
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| White Paper | Q4 2023 |
Finalise Stage 2 of draft White Paper |
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