Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021-Reference-Cited by-同舟云学术

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

Published:2022-06-16 Issue:4 Volume:113 Page:771-774
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Liu Qi¹^ORCID,Huang Ruihao¹,Hsieh Julie¹,Zhu Hao¹^ORCID,Tiwari Mo¹,Liu Guansheng¹,Jean Daphney¹,ElZarrad M. Khair²,Fakhouri Tala²^ORCID,Berman Steven³,Dunn Billy³,Diamond Matthew C.⁴,Huang Shiew‐Mei¹^ORCID

Affiliation:

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

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2668

Reference10 articles.

1. Application of Machine Learning in Drug Development and Regulation: Current Status and Future Potential

2. Long short-term memory recurrent neural network for pharmacokinetic-pharmacodynamic modeling

3. Neural-ODE for pharmacokinetics modeling and its advantage to alternative machine learning models in predicting new dosing regimens

4. A novel approach for personalized response model: deep learning with individual dropout feature ranking

5. US Food and Drug Administration.Letter of intent determination letter DDT BMQ000105 (2020). Accessed January 16 2022.

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