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Tobacco products can lead to chronic health effects that can take decades to manifest (e.g., lung cancer can take 20+ years), which would require long-term studies to assess. Population models and simulations provide a desirable alternative for making estimates and predictions of likely impact on morbidity/mortality at the population level. Mathematical, computational, and simulation models are used with the purpose to assess the impact of new or existing tobacco products and/or regulatory activities on the population as a wholecan also help guide regulatory activities such as new product authorizations and policy development. Such models take into consideration both users and nonusers of tobacco products. Various types of population models may be used for these purposes, and include cohort models, agent-based models, deterministic and stochastic systemic dynamic models, and static and dynamic social network 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, how they are represented in CDISC standards for submission to a regulatory authority.

• Sponsors need to submit software code/programs (applicant can choose whatever software they want; so we need to provide some guidance). Unknown User (a.paredes) to work internally to see if they can come up with some ideas.
  • ADRG, define can be used to provide some information and links to programs
    • ADRG template has a place to document programs
    • ARM  (analysis results metadata) allow for program references and links to programs
  • We would need input on what the specific requirements should be. TCG has some language regarding programs