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The objective of population modeling is to study the impact of tobacco products on the population as whole. Input parameters include demographic information, tobacco use transition probability and mortality and/or morbidity. The input parameters are typically derived from population-level sources (e.g., census data or other population-level surveys). However, depending on the objective, other sources of data may be used. When using these other sources, steps should be taken to ensure they are representative of the population.

In this section, the inputs to these models In this section, these models are discussed with regard to inputs to, and outputs from the models, and how these models contribute to studies of tobacco products, and how they are represented in CDISC standards for submission to a regulatory authority .

"this section covers --→

We need to note "Simulation". Replaced "or" 

To assess the impact to the population as a whole, estimations or real-world data reflecting product risk and behavior are used to assess changes in mortality or morbidity in a population. 

Post-market (research purpose - 7/14/22 - team feels this can be handled by writing. Revisit after we're done the population modeling section)
Updating previous modeling work based on real-world evidence once the product is marketed. e.g., updating transition probabilities.

Includes additional data from the following, which serve as inputs to updating the inputs described in the previous section on population modeling:

• surveys
• obs studies (longitudinal cross-sectional)
• EHR (retrospective)

Parameters used as inputs to population modeling; not subject-level data. 

Models are made up of  inputs, programs/coding, and outputs

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are discussed. “Model outputs are not currently covered in this section but may be covered in a later release.” However, regulatory agencies expect full information to replicate the analysis based in the outputs.

Chris to look for language pointing back to CTP for full guidance…

Transition into discussion of examples - to be discussed:

Selection of initial model input parameters is an important step during model development. Input parameters are typically chosen to represent characteristics of the entire population: transitional probabilities (initiation, cessation, quitting, switching) and health outcome (mortality and/or morbidity rates). The initial values of these parameters are typically estimated from sources representative of the population, such complex probability population survey and census. 

Categories of Inputs

• Product risk
  • need input from Unknown User (a.paredes) . Come back to later, time permitting
• transition probabilities/rates (behavior)
  • initial population (file) - describing states of tobacco use covered by the model
  • transition probability (file)
• population attributes broken down by demographic characteristics (files)
  • birth rate 
  • morbidity/mortality 
  • initial tobacco prevalence
  • immigration rates 
• programs/coding
  • ...
• Outputs
  • ...

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