Method Validation approaches for analysis of Constituents in ENDS.

Introduction:
This summary will provide an overview of a study that assessed the method validation approaches used in the analysis of constituents in electronic nicotine delivery systems (ENDS). The study aimed to determine how many peer-reviewed publications reporting chemical quantities and/or yields from ENDS have included adequate method validation characteristics for appropriate interpretation of data quality. This information is critical for informing tobacco regulatory science.

Key Points:

* The study searched five databases for ENDS publications between January 2007 and September 2018 and identified 173 relevant publications.
* The study defined marginally validated methods (MVMs) as methods that report three or more International Conference on harmonisation (ICh) method validation characteristics, state the method was validated, cite their own previous publication(s) that report MVMs, or use a method within the accreditation scope of an accredited laboratory.
* Of the 173 publications, 97 (56%) report MVMs in their studies.
* The study found that not all publications report sufficient information regarding test method validity, which can impact the accuracy and reliability of the data reported.
* The study compared the method validation characteristics across all 173 publications and found that the most commonly reported test method characteristic is LOD (47%).
* The study also found that 25% of the publications do not report any validated characteristics.
* The study compared the accuracy, precision, and linearity reported in publications to the recommendations in the ICh guidelines and found that most publications rely on one of the elements listed in the guidelines instead of a combination as the guidelines recommend.

Main Message:
The study highlights the importance of adequate method validation in the analysis of constituents in ENDS. The study found that while many publications report MVMs, not all publications report sufficient information regarding test method validity. This lack of information can impact the accuracy and reliability of the data reported and may hinder the ability to inform tobacco regulatory science. The study suggests that researchers should include adequate method validation characteristics in their publications to ensure the accuracy and reliability of the published analytical data.

Reilly SM, Cheng T, DuMond J. Method Validation approaches for analysis of Constituents in ENDS. Tobacco regulatory science. 2020;6(4):242-265. doi:10.18001/TRS.6.4.3