Project | ScopeScope |
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 |
Paula Rowley (Nicola Newton, PHUSE Project Assistant |
)paula@phuse
Status |
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colour | Blue |
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title | Current Status |
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Q3/42021The group have started to draft their White Paper and is currently in progress.
Wide scope of examples have now been gathered. |
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- Completed incorporating the second round of comments from FDA reviewers.
- Will be routing the Stage 1 white paper for the PHUSE executive review and thereafter post for public review.
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Objectives & Deliverables |
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Timelines | Draft document for review | Q32021 |
Users Guide or White Paper | Q32021 |
Project Members | Organisation |
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Amelia Pang | Sanofi |
Charles Beasley | MSN |
Darshan Bhatt | Industry |
Eileen Navarro Almario | FDA |
Hongli Lu | Merck |
John Marciank | AbbVie |
Patrick Hannon | MMS |
Paul Hayashi | A2 Healthcare Corporation |
Preeti Venkataraman | FDA |
Swarnalatha Reddy | Industry |
Veronical Pei Yang | FDA |
William Palo | AbbVie |
Shayami | Eli LillyTimelines |
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Finalise Stage 1 of draft White Paper | Q4 2023 |