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https://www.sciencedirect.com/science/article/pii/S004060311930752X

This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for an Electronic Nicotine Delivery System (ENDS) (Vapes). 

The following example illustrates the representation of ENDS tobacco product identifiers and descriptors using the TO domain. Note that this example makes use of TOCAT (Category of Tobacco Product ID Element, a permissible variable) to emphasize and differentiate the two distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors. 

The manufacturing parameter specifications of the ENDS product as intended for used are represented in the Product Design Parameters (PD) domain is used to represent design parameter specifications of the tobacco product. Each property is identified using controlled terminology and is represented in PDPARMCD/PDPARM.. The example below shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally. 

The Finally, the Tobacco Product Testing (PT) dataset below shows the domain is used to represent the actual results of testing used to demonstrate the manufactured ENDS device's product for conformance to the tobacco product design parameters . Note that the values of PTESTCD/PTEST are the same values shown in PDPARMCD/PDPARM in the PD example aboveabove. PTCAT is a required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only one replicate per parameter is shown. Note that PTREPNUM (repetition number) =1 for all rows.