Introduction to statistical population modeling of tobacco products and their impact on health
This presentation will introduce the basic concepts of population modeling in a non-technical, conceptual manner. The utility of modeling will be described, emphasizing the importance of such modeling in the context of FDA's population-impact standards for Pre-Market Tobacco Applications and Modified Risk Tobacco Product Applications, which require considering and balancing or netting-out impacts on users and non-users of existing tobacco products, in a pre-market setting. Several examples of modeling will be briefly presented to illustrate their common focus on transitions among states of tobacco product use (including non-use). Other common elements, such as the extensive use of sensitivity testing and tipping-point analyses will be discussed. Following the description of elements that are common to all modeling approaches, the presentation will then turn to how models may differ with regard to such matters as their assumptions, sources of inputs, nature of their outputs, and their underlying mechanics. In addition to introducing modeling in general, these concepts lay the foundation for the presentations that will follow, which will present specific models and applications.