Inactive

The Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) is in need of an in vitro exposure system and smoking machine to facilitate the research of human cell cultur... The Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) is in need of an in vitro exposure system and smoking machine to facilitate the research of human cell cultures in direct exposure to airborne substances such as smoke generated by electronic cigarettes. One of the goals of the CDER research governance counsel is to maintain scientific readiness to address public health threats and to support the treatment of those with opioid use disorder. To support this goal, CDER id studying the risk of vaping opioid drugs by developing an in vitro method to estimate the bioavailability of opioid drugs after vaping. The requested system will allow determining the epithelial permeability as an estimate for bioavailability of opioid drugs after vaping using human cell culture. This in vitro exposure system will be connected to smoking machine for vaping study but also the exposure system can be adapted to other aerosols generating instruments. These criteria will help in comparing the epithelial permeability after vaping of opioids with epithelial permeability of marketed nasal products. The Smoking Machine and Exposure System (SMES) will provide valuable information regarding safety and quality of drug products and support CDER’s mission critical missions.