Investigation of number of replicate measurements required to meet cigarette smoke chemistry regulatory requirements measured under Canadian intense smoking conditions

Publication date: Available online 12 June 2019Source: Regulatory Toxicology and PharmacologyAuthor(s): Alison Eldridge, Tatiana Betson, Marcos Vinicius Gama, Graham Errington, Kevin McAdamAbstractThere has been increased interest in recent years in regulatory reporting of cigarette smoke toxicants. There is a great deal of diversity in current regulatory standards around the world in terms of the identities of regulated toxicants, and the number of replicate analyses stipulated for their measurement. Furthermore, analytical methods developed collaboratively by several organisations and intended for regulatory analysis generally differ in their recommended replicate numbers to those stipulated by regulators. In view of these inconsistencies, we undertook an exercise to examine the most appropriate numbers of replicates required for regulatory analysis of cigarette smoke toxicants.A one-point-in-time sampling exercise was undertaken of the German cigarette market, with 161 brands sampled and analysed in a single laboratory using Canadian Intense smoking conditions. Seven replicate measurements were made for each analyte and product, other than nicotine, CO and nicotine-free dry particulate matter for which eight replicate measurements were made. After confirming the absence of order of analysis effects, a variety of statistical tests (such as group assessment, paired comparisons, linear regression models and ratio analysis) were conducted examining mean values, SDs and CVs to ...

Source: Regulatory Toxicology and Pharmacology - June 12, 2019 Category: Toxicology Source Type: research