Statistics Meeting Book (May 15, 2019)

IV.

OTHER PROJECTS & DISCUSSIONS (All – 11:05AM-11:10AM) (Other projects and discussions)

a. Glossary of Terms & Definitions (Delayed for now, until other projects complete?) b. Waiting for guidance from OMB on what is needed from Committee on Statistics? 1. Repeatability: Please see Documents/Links found in Meeting Notebook a. JCGM 200:2008(E) defined in section 2.20 b. CCMAS: The Codex Committee on Methods of Analysis and Sampling_July 2009 c. ISO 5725-1 d. USP e. ICH f. Analytical Methods Committee, Royal Society of Chemistry g. Eurachem 2. Intermediate Precision (RSDi) 3. False Positive/False Negative Rates/Sensitivity vs. Probability of Detection (POD) 4. Linearity 5. Clarification on Number of Calibration Points 6. LOD/LOQ c. Statistics Committee’s Terms of Reference (ToR) Update – All, ToR Subcommittee 1. Latest version – v8 has been approved by OMB 2. Response received from Executive Director promising to speed up the e-ballot process. V. NEW BUSINESS (All – 11:10AM-11:25AM) a. Proposed Scientific Sessions at Annual Meeting, Tuesday, September 10, 2019 @ 3:00 – 4:30pm: 2. Equivalency of DNA sequencing, HPTLC Chromatographic Analysis and Botanical Microscopy Methodologies for Botanical Identity: A Statistical Evaluation. Presenter S. Sudberg 3. Rumpelstiltskin Statistics: Spinning Proficiency Test Data “Straw” into “Gold”. Presenter, P. Wehling or TBD 4. Application of the Lifecycle Approach. Presenter J. Weitzel b. Chairs & presenters must pre-register for the Annual Meeting by May 21 1. Update on the systematic review and meta-analysis of quantitative chemical collaborative studies published in J. AOAC, I, from 2000 – 2018 based on the logarithmic metamer pC. Presenter S. Sudberg

c. Potential new committee members: Waiting for guidance from Staff? 1. Daniel Tholen, MS - tholen.dan@gmail.com 2. Dan Morse, 3M - danjmorse22@mmm.com (651-733-6087) 3. Liwen Chen, USP - lzc@usp.org 4. Soo Kwang Lee, FDA - Sookwang.Lee@fda.hhs.gov 5. Eric Milgram – eric.milgram@gmail.com d. Manuscript Reviews: 1. None at this time VI. SCHEDULE NEXT STATISTICS COMMITTEE MEETING (All – 11:25AM-11:30AM) Next Statistics Committee meeting dates/times (other options, if necessary) a. Proposed for Wednesday, June 19, 2019 at 10:30 am ET VII. ADJOURN MEETING (All – 11:30PM ET)

*Requires a vote

version 2

Draft meeting agenda is subject to change without notice