The Role of Artificial Intelligence in Drug Discovery and Pharmaceutical Development: A Paradigm Shift in the History of Pharmaceutical Industries.

作者信息

Vidiyala Nithin, Sunkishala Pavani, Parupathi Prashanth, Nyavanandi Dinesh

机构信息

Small Molecule Drug Product Development, Cerevel Therapeutics, Cambridge, Massachusetts, 02141, USA.

Process Validation, PCI Pharma Services, Bedford, New Hampshire, 03110, USA.

出版信息

AAPS PharmSciTech. 2025 May 14;26(5):133. doi: 10.1208/s12249-025-03134-3.

Abstract

In today's world, with an increasing patient population, the need for medications is increasing rapidly. However, the current practice of drug development is time-consuming and requires a lot of investment by the pharmaceutical industries. Currently, it takes around 8-10 years and $3 billion of investment to develop a medication. Pharmaceutical industries and regulatory authorities are continuing to adopt new technologies to improve the efficiency of the drug development process. However, over the decades the pharmaceutical industries were not able to accelerate the drug development process. The pandemic (COVID-19) has taught the pharmaceutical industries and regulatory agencies an expensive lesson showing the need for emergency preparedness by accelerating the drug development process. Over the last few years, the pharmaceutical industries have been collaborating with artificial intelligence (AI) companies to develop algorithms and models that can be implemented at various stages of the drug development process to improve efficiency and reduce the developmental timelines significantly. In recent years, AI-screened drug candidates have entered clinical testing in human subjects which shows the interest of pharmaceutical companies and regulatory agencies. End-end integration of AI within the drug development process will benefit the industries for predicting the pharmacokinetic and pharmacodynamic profiles, toxicity, acceleration of clinical trials, study design, virtual monitoring of subjects, optimization of manufacturing process, analyzing and real-time monitoring of product quality, and regulatory preparedness. This review article discusses in detail the role of AI in various avenues of the pharmaceutical drug development process, its limitations, regulatory and future perspectives.

摘要

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