Method Validation Approaches for Analysis of Constituents in ENDS

Area of Science:

• Analytical Chemistry
• Tobacco Regulatory Science
• Chemical Analysis

Background:

• Electronic nicotine delivery systems (ENDS) research requires reliable chemical quantity and yield data.
• Method validation is essential for interpreting the quality and accuracy of analytical results.
• Current publications on ENDS may not consistently report sufficient validation characteristics.

Purpose of the Study:

• To assess the extent to which peer-reviewed publications on ENDS report adequate method validation characteristics.
• To determine the data quality for informing tobacco regulatory science.
• To highlight the need for standardized reporting of validation data.

Main Methods:

• A systematic literature search was conducted across five major databases for ENDS publications from January 2007 to September 2018.
• 173 relevant publications were analyzed for the reporting of marginally validated methods (MVMs).
• MVMs were defined by criteria including reporting 3+ ICH validation characteristics, stating method validation, citing previous validation studies, or using accredited laboratory methods.

Main Results:

• 56% of the analyzed publications (97 out of 173) reported marginally validated methods (MVMs).
• This level of validation was consistent across studies measuring the majority of the 28 different chemicals.
• A significant portion of ENDS publications do not fully report method validation.

Conclusions:

• There is a critical need for authors to report sufficient method validation characteristics in ENDS publications.
• Adherence to appropriate guidance for reporting validation is necessary for data accuracy and reliability.
• Improved reporting standards will enhance the interpretation of analytical data to support tobacco policy development.