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3.3 Example reiterating the importance of involving the regulatory agency early in the experimental development process and to clearly describe the NAMs In the decision summary of a PMTA where five separate in vitro organotypic studies were submitted, it was noted The experimental approach taken in these studies included using methods that are exploratory, have not been independently validated, and have unknown utility for regulatory use

This process of inflammation-induced loss of tight and adherens junctions predisposes the epithelium to further infection and exacerbates the persistent chronic inflammatory state seen in COPD

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