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Inhalation February 2023 17 References 1. Petersson, G., Pipeline trends and challenges in pulmonary delivery. ONdrugDelivery Magazine, 2018. (92): p. 4-8. 2. Sedo, K., et al., Global drug delivery & formula- tion. JIIP, 2020. 20: p. 18-23. 3. Weibel, E.R., et al., Morphometry of the human lung. Vol. 1. 1963: Springer. 4. Cidem, A., et al., Modifying and integrating in vitro and ex vivo respiratory models for inhalation drug screening. Front Bioeng Biotechnol, 2020. 8: p. 581995. 5. Haghi, M., et al., Across the pulmonary epithe- lial barrier: Integration of physicochemical prop- erties and human cell models to study pulmonary drug formulations. Pharmacol er, 2014. 144(3): p. 235-252. 6. Jabba, S.V., et al., Chemical adducts of reactive flavor aldehydes formed in e-cigarette liquids are cytotoxic and inhibit mitochondrial function in respiratory epithelial cells. Nicotine Tob Res, 2020. 22(Suppl 1): p. S25-S34. 7. Jia, J., et al., Investigation of the impact of PM(2.5) on the ciliary motion of human nasal epithelial cells. Chemosphere, 2019. 233: p. 309-318. 8. Huang, J., et al., Toxicity of micro(nano)plastics with different size and surface charge on human nasal Further considerations is article discusses options and advancements in in vitro methodologies that can be used to mimic in vivo conditions during research and development of inhalation products. e development of novel mod- els that are physiologically relevant to the human lung can improve the predictability of pharmacoki- netics and pharmacodynamics. ey can also acceler- ate the translation of novel therapies to clinical trials and help provide better health outcomes for patients with chronic respiratory conditions. In vivo models continue to be the mainstay assess- ment for inhalable products by virtue of their ability to administer an aerosolized formulation, using the ideal dose, on individual organisms. However, dif- ferences in lung anatomy and physiology between humans and animal models, have limited the trans- lation of experimental results from animal studies. Animal models can also be expensive, time consum- ing to use and have ethical restrictions for use in research studies. Consequently, researchers should be aware of these fundamental principles under- lying the use of animals and consider "the 3R's" of replacement, reduction and refinement. At the same time, the concerns listed above reinforce the unmet need for relevant data collected using in vitro respiratory model systems that can be realistically translated in vivo. Accelerate Your Drug Development Reduce the number of samples and processing time with Abbreviated Impactor Measurement (AIM) equipment. Focus on the data points necessary for early stage development and simplify long-term QA/QC testing processes. Customizable rNGI, FSA, and FSI options available. To learn more about shortening process time, visi tsi.com/aim Accelerate Your Drug Development