Artificial intelligence in pharmaceutical regulatory affairs.

Autor: Patil RS; Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India., Kulkarni SB; Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India., Gaikwad VL; Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India; Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur 844 102, Bihar, India. Electronic address: vinod_gaikwad29@yahoo.com.
Jazyk: angličtina
Zdroj: Drug discovery today [Drug Discov Today] 2023 Sep; Vol. 28 (9), pp. 103700. Date of Electronic Publication: 2023 Jul 12.
DOI: 10.1016/j.drudis.2023.103700
Abstrakt: Artificial intelligence (AI) refers to the ability of a computer to carry out tasks associated with human intelligence, including thinking, discovering, and learning from prior experience. AI can be integrated to simplify the complexity of pharmaceutical regulatory affairs. AI tools can be applied to automate regulatory processes such as administrative work, dossier filling, data extraction, auditing, the implementation of regulations, and quality management. AI creates process links and reduces complexity, resulting in a more efficient management system. Human-AI interaction opens up new opportunities in regulatory affairs. This article explores the potential role of AI in pharmaceutical regulatory affairs.
(Copyright © 2023 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE