Versions Compared

Old Version 16

changes.mady.by.user Wendy Dobson

Saved on

compared with

New Version Current

changes.mady.by.user Nicola Newton

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Image Modified


for analysis outliersshifts
Project Scope

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

for analysis and displays for Laboratory Data, with a focus on Phase 2-4 clinical trials and integrated submission documents. There have been 2 previous White Papers on this topic (1 for central tendency in 2013 and 1 for

Outliers/

Shifts in 2015). This paper will combine two method types and update recommendations given the advancement in interactive options. 



Project LeadsEmail
Charles Beasley, Beasley Pharmaceutical and Biotechnology Consultingcharlesmbeasleyjr@msn.com

Wei Wang 

wang_wei_v@lilly.com

Wendy Dobson (PHUSE Project Manager)

Christopher Smith, FDAchristopher.smith2@fda.hhs.gov
Nicola Newton, PHUSE Project Assistant

nicky@phuse

wendy@phuse

.global


Status
colourBlue
titleCurrent Status

 Q12021Strategy in place to create White Paper (won’t be a version 2) but an appendix/supplement of Version 1

Q3 2023

Project Closed.



Objectives & Deliverables 

Timelines 

Align on next steps 

Q2 2023
DeliverablesTimelinesUsers guide or White PaperQ32021Project MembersCompanyAmelia PangSanofiDarshan BhattIndustryHongli LuMerckMary NilssonEli LillyMercy NavarroGeneNancy BruckenCSGNhi BeasleyFDARaj PhadtareCorvus PharmaSumit PradhanIndustry