OMA Consulting Protocol Review: OMACON-2019-2

2.7.6 Use a generalized linear model to determine whether time points and/or lots differ.

3.0

REPORT FORMAT

A validation study report in the format shown in Appendix 4 is to be submitted by the method developer at the completion of data collection. This report is to incorporate all the results generated through SLV studies. A call for experts will be made and an AOAC Expert Review Panel (ERP) will be conveyed to review the method. Once reviewed and any revisions are made, the ERP will determine if the test kit is acceptable for First Action Official Method of Analysis SM status. If acceptable, the method developer must submit the report for publication in the Journal of the AOAC INTERNATIONAL .

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