Method Validation Approaches for Analysis of Constituents in ENDS.
作者： Samantha M. Reilly , Tianrong Cheng , Jenna DuMond
DOI: 10.18001/TRS.6.4.3
关键词: Regulatory science 、 Validation Characteristics 、 Nicotine delivery 、 Data quality 、 Reliability (statistics) 、 Accreditation 、 Medical physics 、 Web of knowledge 、 Computer science
摘要: 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 informing tobacco regulatory science. Methods searched 5 databases (Web Knowledge, PubMed, SciFinder, Embase, EBSCOhost) ENDS between January 2007 and September 2018. Of 283 screened, 173 were relevant analysis. identified that report a certain degree control quality, ie, marginally validated methods (MVMs). MVMs refer to that: (1) 3 or more International Conference on Harmonisation (ICH) characteristics, (2) state was validated, (3) cite their own previous publication(s) MVMs, (4) use within accreditation scope an accredited laboratory. Results Overall, 97 (56%) studies. This percentage also reflects distribution majority 28 chemicals measured by MVMs. Conclusions study highlights need sufficient following guidance ensure accuracy reliability published analytical proper interpretations may support policy.
sci-hub.st 参考文章(152)
María C. Talio, Karen Zambrano, Marcos Kaplan, Mariano Acosta, Raúl A. Gil, Marta O. Luconi, Liliana P. Fernández, New solid surface fluorescence methodology for lead traces determination using rhodamine B as fluorophore and coacervation scheme: Application to lead quantification in e-cigarette refill liquids. Talanta. ,vol. 143, pp. 315- 319 ,(2015) , 10.1016/J.TALANTA.2015.04.078
Esther Marco, Joan O. Grimalt, A rapid method for the chromatographic analysis of volatile organic compounds in exhaled breath of tobacco cigarette and electronic cigarette smokers. Journal of Chromatography A. ,vol. 1410, pp. 51- 59 ,(2015) , 10.1016/J.CHROMA.2015.07.094
Sandra L. Blair, Scott A. Epstein, Sergey A. Nizkorodov, Norbert Staimer, A Real-Time Fast-Flow Tube Study of VOC and Particulate Emissions from Electronic, Potentially Reduced-Harm, Conventional, and Reference Cigarettes. Aerosol Science and Technology. ,vol. 49, pp. 816- 827 ,(2015) , 10.1080/02786826.2015.1076156
Jason S. Herrington, Colton Myers, Electronic cigarette solutions and resultant aerosol profiles. Journal of Chromatography A. ,vol. 1418, pp. 192- 199 ,(2015) , 10.1016/J.CHROMA.2015.09.034
Konstantinos Farsalinos, Gene Gillman, Konstantinos Poulas, Vassilis Voudris, Tobacco-Specific Nitrosamines in Electronic Cigarettes: Comparison between Liquid and Aerosol Levels. International Journal of Environmental Research and Public Health. ,vol. 12, pp. 9046- 9053 ,(2015) , 10.3390/IJERPH120809046
Maciej L. Goniewicz, Peter Hajek, Hayden McRobbie, Nicotine content of electronic cigarettes, its release in vapour and its consistency across batches: regulatory implications Addiction. ,vol. 109, pp. 500- 507 ,(2014) , 10.1111/ADD.12410
Barbara Davis, Aladino Razo, Eugene Nothnagel, Mathew Chen, Prue Talbot, Unexpected nicotine in Do-it-Yourself electronic cigarette flavourings Tobacco Control. ,vol. 25, ,(2016) , 10.1136/TOBACCOCONTROL-2015-052468
Reham M. Haleem, Maissa Y. Salem, Faten A. Fatahallah, Laila E. Abdelfattah, Quality in the pharmaceutical industry - A literature review Journal of The Saudi Pharmaceutical Society. ,vol. 23, pp. 463- 469 ,(2013) , 10.1016/J.JSPS.2013.11.004
Otmar Geiss, Ivana Bianchi, Francisco Barahona, Josefa Barrero-Moreno, Characterisation of mainstream and passive vapours emitted by selected electronic cigarettes. International Journal of Hygiene and Environmental Health. ,vol. 218, pp. 169- 180 ,(2015) , 10.1016/J.IJHEH.2014.10.001
Sarah K. Branch, Guidelines from the International Conference on Harmonisation (ICH). Journal of Pharmaceutical and Biomedical Analysis. ,vol. 38, pp. 798- 805 ,(2005) , 10.1016/J.JPBA.2005.02.037