Statistics Meeting Book (September 19, 2018)

1. Need to have the Word copies of the Annexes for Appendix J, to be able to work with equations easily: a. Robert LaBudde b. Paul Wehling

Volunteers needed to check equations modified by Paul: 1. Qian Graves 2. Jane Weitzel

3. Hilde Skår Norli 4. Sidney Sudberg

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 Paul: The new Word file (converted from the pdf file) has many missing equations and we will need to update the file with all equations. In order to make a clean and complete file for OMB’s review and approval, we will need to merge the files. This task was discussed over the last call, and here are the updates: Delia checked with AOAC Publications but they could not find the original WORD file (before it was converted to pdf file). During this call, Robert searched and found a 2011 Word file with equations on it, before the file was converted to pdf file. (we still need to double check and compare this one with the pdf file, to make sure that this word file was the latest version, right before converting to the final pdf file) Paul will be traveling to FDA CFSAN for a meeting in Sept., and he asked Qian to help with copy- paste to make the file complete, Qian volunteered for the project. There is a software dealing with typing equations on WORD (MathgType) that Paul used to have and it made the equation-typing much easier, but since we could copy-paste the missing equations and text from the old word file to the new word file, we may not need to get this software for this project. c. Statistics Committee’s Terms of Reference (ToR) Update – All, ToR Subcommittee 1. Latest version – v8 has been approved by OMB a. Sent to Committee on Statistics b. Board of Directors to vote in July?

*Requires a vote

version 2

Draft meeting agenda is subject to change without notice