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In the guidance for industry on PMTAs for ENDS, CTP documented that a data package might require the following, non-clinical investigations, if available ( FDA, 2019a ): In vitro toxicology studies (e.g., genotoxicity studies or cytotoxicity studies) Computational modeling of the toxicants in the product (to estimate the toxicity of the product) In vivo toxicology studies (to address unique toxicology issues that cannot be addressed by alternative approaches) Throughout this guidance document, CTP states its support for reducing, replacing, and/or refining the use of animal testing where adequate and scientifically valid NAMs can be substituted (FDA, 2019a)

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The randomization schedule will be generated by the research pharmacist under guidance of the co-investigator statistician and stored securely in the pharmacy

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