| Popis: |
The purpose of a clinical assessment program for electronic nicotine delivery products (ENDPs) is to demonstrate that ENDPs have the potential to reduce the risk and harm caused by cigarette smoking. To achieve this objective, ENDPs should be acceptable alternatives to cigarettes for current smokers. Therefore, ENDP use should lead to a nicotine absorption profile that resembles that of cigarettes. This can be assessed in pharmacokinetics studies that also provide additional insights into the acceptability of ENDPs. Second, ENDPs should reduce the risk of smoking-related disease. Therefore, switching from cigarette smoking to ENDP use must lead to a reduction in toxicant exposure approaching that following smoking abstinence. This can be assessed in reduced exposure studies conducted with smokers who have either switched to an ENDP or abstained from smoking. This reduction in toxicant exposure should lead to positive changes in biomarkers of potential harm (BoPHs), which can be assessed in exposure response studies. The data obtained from a clinical assessment program should provide evidence that switching from cigarette smoking to ENDP use leads not only to a reduction in toxicant exposure approaching that following smoking abstinence but also to positive changes in BoPHs. The data should also provide early insights into product acceptance and use behavior, which should be further examined by dedicated behavioral studies. This chapter will use the clinical ENDP assessment program developed by Philip Morris International as an example. |
