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The reason for that approach is because when you find the balance that you want between those two tobaccos, then it's really easy to figure out how much Latakia is too much." With a base of Virginias, typically balanced between Red and Bright Virginias, Jeremy then incorporates the Orientals and balances the new combination

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