Statistics Meeting Book (December 13, 2017)

AOAC INTERNATIONAL COMMITTEE ON STATISTICS Draft Meeting Agenda Wednesday, December 13, 2017 Meeting Start Time: 11:00AM (Eastern US)

Chair: Sidney Sudberg (Alkemists Pharmaceuticals) ______________________________________________________________________________ ( Need member to volunteer to take the minutes )

I. WELCOME & INTRODUCTION (Sudberg – 11:00AM‐11:10AM) *

Sidney Sudberg will call the meeting to order, welcome and introduce the members of Statistics Committee. Members will review the AOAC policy documents and vote on the draft meeting agenda.

II. REVIEW OF MEETING AGENDA & MINUTES (All – 11:10AM-11:15AM) * The members of the Statistics Committee will review and vote on the November 15, 2017 meeting minutes and the December 13, 2017 meeting agenda.

III.

CURRENT METHOD CONFORMITY ASSESSMENT PROJECTS (Wehling/LaBudde/Sudberg/Thompson/Graves – 11:15AM-11:35AM)

Progress updates a. Statistics for Microbiology Methods Validation - Paul Wehling & Robert LaBudde (Leads) 1. Progress for Internal Validation Plan 2. Next Subcommittee Meeting?

Volunteers: 1. Caryn Thompson

4. Mike Zapf 5. Hilde Skår Norli 6. Sidney Sudberg

2. Qian Graves 3. Jane Weitzel

b. Changes to Appendix J (in progress) - Paul Wehling & Robert LaBudde (Leads) 1. Quantitative methods need changes (performed during &/or after validation) a. Candidate minus Reference b. New method of calculating the CI for the paired dPod c. Use of Z (n) vs. t (n-1) d. Removal of reference to Welch/Satterthwaite t-test? e. Chi-Square Test Calculator (Robert/Paul) http://lcfltd.com/AOAC/aoac-binary-v2-5.xlsx i. To be discussed with Appendix J changes c. Statistics Committee’s Terms of Reference (ToR) Update – All, ToR Subcommittee 1. Latest version in progress – v8 a.

Committee voted on final changes to be accepted & then submit to the OMB for initial approval

*Requires a vote

version 1

Draft meeting agenda is subject to change without notice