Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021

Affiliations

¹ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
² Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
³ Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
⁴ Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.

^# Contributed equally.

Qi Liu et al. Clin Pharmacol Ther. 2023 Apr.

. 2023 Apr;113(4):771-774.

doi: 10.1002/cpt.2668. Epub 2022 Jun 16.

¹ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
² Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
³ Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
⁴ Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.

^# Contributed equally.

No abstract available

References

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1. Lu, J., Deng, K., Zhang, X., Liu, G. & Guan, Y. Neural-ODE for pharmacokinetics modeling and its advantage to alternative machine learning models in predicting new dosing regimens. iScience 24, 102804 (2021).
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1. US Food and Drug Administration. Letter of intent determination letter DDT BMQ000105 <https://www.fda.gov/media/143081/download> (2020). Accessed January 16, 2022.