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This section illustrates how to use CDISC standards to represent various aspects of the identification, descriptive characteristics, product design, and testing of tobacco products that occur separately from product testing in human subjects.  The concepts illustrated in the examples include:

• How to uniquely identify a tobacco product under study, or a predicate/comparator product using the Sponsor-defined Tobacco Product Identifier (SPTOBID) variable, which is used in any applicable dataset throughout the product development lifecycle to identify the tobacco product that is a focal point of a record. or records
• How to represent tobacco product identifying and descriptive parameters using the Tobacco Product Identifiers and Descriptors (TO) domain.
• How to represent product design parameter specifications using the Product Design Parameters (PD) domain, and the results of testing for conformance to those specifications using the Tobacco Product Testing (PT) domain.
• How to represent and quantify tobacco ingredients, non-tobacco ingredients, and additives using the Tobacco Ingredients (IT) domain, the Non-Tobacco Ingredients (IN) domain, and the Ingredient Quantities by Component (IQ) domain.
• How to represent tobacco product testing for HPHC content using the Tobacco Product Testing (PT) domain.
• How to represent smoking machines and smoking regimens using the Device Identifiers (DI) domain, and the Device In-Use Properties (DU) domain, and how to relate those to measurements of analytes using the DURERFID and PTREFID variables.
• How to represent stability study results using the Tobacco Product Testing (PT) domain..
• How to represent storage conditions used in stability studies using the Environmental Storage Conditions (ES) domain, and how to relate the parameters of those conditions to the stability study results using the STOCONID variable.

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