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Project Scope

This project team will create a users guide or White Paper with recommendations for

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analysis and displays for

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Laboratory Data, with a focus on Phase 2-4 clinical trials and integrated submission documents.

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There have been 2 previous White Papers on this topic (1 for central tendency in 2013 and 1 for

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Outliers/

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Shifts in 2015).

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This

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paper will combine

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two method types and update recommendations given the advancement in interactive options. 



Project

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Wei Wangwang_wei_v@lilly.com
LeadsEmail
Charles Beasley, Beasley Pharmaceutical and Biotechnology Consultingcharlesmbeasleyjr@msn.com
Christopher Smith, FDAchristopher.smith2@fda.hhs.gov
Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


Status
colourBlue
titleCurrent Status
Q3 2023

Project Closed.



Objectives & Deliverables 

Timelines 

Align on next steps 

Q2 2023