Supporting evidence-based analysis for modified risk tobacco products through a toxicology data-sharing infrastructure

• DOI: 10.12688/f1000research.10493.2
• Publication Date: 2017-09-05T15:35:15Z
• Authors: Stéphanie Boué; Thomas Exner; Samik Ghosh; Vincenzo Belcastro; Joh Dokler; David Page; Akash Boda; Filipe Bonjour; Barry Hardy; Patrick Vanscheeu...; Julia Hoeng; Manuel Peitsch
• Keywords: Data Sharing; Regulatory Science

<ns4:p>The US FDA defines modified risk tobacco products (MRTPs) as that aim to reduce harm or the of tobacco-related disease associated with commercially marketed products. Establishing a product’s potential an MRTP requires scientific substantiation including toxicity studies and measures relative those cigarette smoking. Best practices encourage verification data from such through sharing open standards. Building on experience gained OpenTox project, proof-of-concept database website (<ns4:ext-link xmlns:ns3="http://www.w3.org/1999/xlink" ext-link-type="uri" ns3:href="http://intervals.science/">INTERVALS</ns4:ext-link>) has been developed share results both <ns4:italic>in vivo</ns4:italic> inhalation vitro</ns4:italic> conducted by Philip Morris International R&amp;D assess candidate MRTPs. As datasets are often generated diverse methods standards, they need be traceable, curated, used well described so knowledge can using science principles tools. The data-management framework here accounts for latest standards research reproducibility. Curated descriptions have prepared in ISA-Tab format stored accessible via search portal INTERVALS website. allows users browse study mechanism (e.g., inflammation, oxidative stress) obtain information relevant design, methods, most important results. Given successful development initial infrastructure, goal is grow this initiative establish public repository 21<ns4:sup>st</ns4:sup>-century preclinical systems toxicology assessment supports principles.</ns4:p>