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Questions: 

1: Studies may be interested in the number of product used per day, and studies never associated the product itself with nicotine exposure. Hence, the unit for the exposure domains would be amount of product- and no specific details provided about the nicotine amounts. Nicotine, is just analysis using the biomarkers.  

Product could be number of cigarettes, number of NRT ( patch, gum etc) . Could  also use volume, or weight of the product.  

2: Studies may be interested in information about the nicotine , as well as the numbers of product used.  This would be represented  in pharmateuctical strengh, and the total amount of the vehicle  and the nicotine. using VAMT . Needs to look at SDTM rules.   

3. When only the amount of product used is of interest, then blinding   


Panel

Use container such as a cartridge or tank.  Hence used CT of container  to be generic. 

  1. DOSEU  - QUID is not included in CT. 

    CANCan Dosing UnitA dosing measurement based on the can unit.(NCI)Can Dosing Unit
    CONTAINERContainer Dosing UnitA dosing measurement based on the container unit.(NCI)Container Dosing Unit
    CIGARCigar Dosing UnitA dosing measurement based on the cigar unit.
    CIGARETTECigarette Dosing UnitA dosing measurement based on the cigarette unit.
    PUFFPuff Dosing UnitA means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI)
    CARTRIDGECartridge Dosing UnitA dosing measurement based on the cartridge unit.(NCI)

    More unit codes as well- PACK, PACKAGE, CIGAR, Cigarettes. POUCH,  


  1. When the EC domain is implemented in conjunction with the EX domain, EXVAMT and EXVAMTU would not be used in EX; collected values instead would be represented in ECDOSE and ECDOSU (and ECVAMT and ECVAMTU as needed).

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