Method Validation Approaches for Analysis of Constituents in ENDS

Abstract

Objective: We assessed how many peer-reviewed publications reporting chemical quantities and/or yields from electronic nicotine delivery systems (ENDS) have included adequate method validation characteristics in the publication for appropriate interpretation of data quality for informing tobacco regulatory science. Methods: We searched 5 databases (Web of Knowledge, PubMed, SciFinder, Embase, EBSCOhost) for ENDS publications between January 2007 and September 2018. Of the 283 publications screened, 173 publications were relevant for analysis. We identified the publications that report a certain degree of control in data quality, ie, the publications that report marginally validated methods (MVMs). MVMs refer to the methods that: (1) report 3 or more International Conference on Harmonisation (ICH) method validation characteristics, (2) state the method was validated, (3) cite their own previous publication(s) that report MVMs, or (4) use a method within the accreditation scope of an accredited laboratory. Results: Overall, 97 publications (56%) report MVMs in their studies. This percentage also reflects the publication distribution for the majority of the 28 chemicals measured by MVMs. Conclusions: This study highlights the need for reporting sufficient validation characteristics following appropriate guidance to ensure the accuracy and reliability of the published analytical data for proper data interpretations that may support policy.