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Drug Approval

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Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.

Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs
Future development of innovative artificial organs is closely related with cutting edge emerging technology. These technologies include brain machine or computer interface, organs made by three dimensional bioprinting, organs designed from induced-pl...

Comparing Machine Learning Algorithms for Predicting Drug-Induced Liver Injury (DILI).

Molecular pharmaceutics
Drug-induced liver injury (DILI) is one the most unpredictable adverse reactions to xenobiotics in humans and the leading cause of postmarketing withdrawals of approved drugs. To date, these drugs have been collated by the FDA to form the DILIRank da...

Deep-learning based repurposing of FDA-approved drugs against dihydrofolate reductase and molecular dynamics study.

Journal of biomolecular structure & dynamics
causes the fatal fungal bloodstream infection in humans called Candidiasis. Most of the species are resistant to the antifungals used to treat them. Drug-resistant poses very serious public health issues. To overcome this, the development of effec...

Exploring the potential of FDA approved anti-diabetic drugs for repurposing against COVID-19: a core combination of multiple computational strategies and integrated artificial intelligence.

Journal of biomolecular structure & dynamics
The latest variant of coronavirus is omicron. The World Health Organization (WHO) designated variation 'B.1.1.529' named omicron as a variant of concern (VOC) on 26 November 2021. By September 2020, it will have infected over 16 million patients and ...

FDA Modernization Act 2.0: An insight from nondeveloping country.

Drug development research
Animal testing is required in drug development research and is crucial for assessing the efficacy and safety of medications before they are commercialized. However, the newly furnished Food and Drug Administration Modernization Act 2.0 has given new ...

Repurposing FDA-approved drugs as NLRP3 inhibitors against inflammatory diseases: machine learning and molecular simulation approaches.

Journal of biomolecular structure & dynamics
Activation of NLRP3 (NOD-like receptor family, pyrin domain-containing protein 3) has been associated with multiple chronic pathologies, including diabetes, atherosclerosis, and rheumatoid arthritis. Moreover, histone deacetylases (HDACs), specifical...

3D printed dosage forms, where are we headed?

Expert opinion on drug delivery
INTRODUCTION: 3D Printing (3DP) is an innovative fabrication technology that has gained enormous popularity through its paradigm shifts in manufacturing in several disciplines, including healthcare. In this past decade, we have witnessed the impact o...

Can Machine Learning Overcome the 95% Failure Rate and Reality that Only 30% of Approved Cancer Drugs Meaningfully Extend Patient Survival?

Journal of medicinal chemistry
Despite implementing hundreds of strategies, cancer drug development suffers from a 95% failure rate over 30 years, with only 30% of approved cancer drugs extending patient survival beyond 2.5 months. Adding more criteria without eliminating nonessen...

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Recenti progressi in medicina
The role of Real-World Evidence (RWE) concerns the entire drug lifecycle; despite widely recognised in the post-marketing, it is still debated in the pre-marketing, mainly as per the identification and analysis of target populations (TPs) for new dru...

AI-Driven Analysis of Drug Marketing Efficiency: Unveiling FDA Approval to Market Release Dynamics.

The AAPS journal
This paper explores a novel approach using generative AI to enhance drug marketing strategies in the US pharmaceutical sector. By leveraging an official dataset sourced from the US government, the AI generates Python code to analyze the time interval...