Decades of studies have conclusively demonstrated that smoking combustible cigarettes, as well as second-hand smoke, are major causes of global morbidity and mortality from a constellation of conditions, including but not limited to chronic disorders such as pulmonary and cardiovascular disease, and multiple types of cancer. The most effective approach to harm reduction is smoking cessation. However, the addictive nature of nicotine and the behavioral aspects of smoking make this a challenging process. There is therefore a significant need to develop and regulate products such as e-cigarettes, that could potentially serve as reduced-risk alternatives. In this paper, we provide background on clinical studies in the US for new tobacco products and delineate how the appropriate testing facilities, equipment, and experienced staff are essential to generating high-quality data.

In this webinar, speaker Christopher Gilmer introduces microbiological testing for raw materials, APIs, and finished products, discusses the validation of methods and product testing requirements, and clarifies general procedures to investigate unexpected results.

This study is aimed at developing a Nanoemulsion formulation of a poorly water-soluble and thermally, oxidatively, and photolytically unstable active pharmaceutical ingredient (API) for ophthalmic application, specifically for the reduction of intraocular pressure (IOP) and to provide neuroprotection.