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Cross Therapeutic Areas

1

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2

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3

Izmailova, E.S., et al. “Evaluation of Wearable Digital Devices in a Phase I Clinical Trial.” Clin Transl Sci. 2019;12(3):247-256. doi.org/10.1111/cts.12602.

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Izmailova, E.S., et al. “Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine.” Clin Transl Sci. 2019;12(6):677-686. doi.org/10.1111/cts.12673.

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Huang, Q., et al. “In-House” Data on the Outside—A Mobile Health Approach.” Clin Pharmacol Ther. 2020;107(4):948-956. doi.org/10.1002/cpt.1790.

7

Goldsack, J.C., et al. “Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs).” NPJ Digit Med. 2020;3(1):55. doi.org/10.1038/s41746-020-0260-4.

8

Izmailova, E.S., et al. “Remote Digital Monitoring for Medical Product Development.” Clin Transl Sci. 2020;14(1):94-101. doi.org/10.1111/cts.12851.

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Izmailova, E.S., et al. “Remote Cardiac Safety Monitoring Through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis.” Digit Biomark. 2021;5(1):103-113. doi: 10.1159/000515110.