| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 8551879 | Regulatory Toxicology and Pharmacology | 2018 | 12 Pages |
Abstract
Biomarker data, collected in clinical studies, can be analyzed to estimate the effects of switching to an MRTP as compared to quitting smoking. Based on transparent assumptions, a link function is formulated that translates these effects into the F-factor. The concepts of 'lack of sufficiency' and 'necessity' are introduced, allowing for a parametrization of a family of link functions. These can be uniformly sampled, thus providing different 'scenarios' on how biomarker-based evidence can be translated into the F-factor to inform the PHIM.
Keywords
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Authors
Florian Martin, Gregory Vuillaume, Gizelle Baker, Zheng Sponsiello-Wang, Paolo F. Ricci, Frank Lüdicke, Rolf Weitkunat,