AIMC Topic: Drug Approval

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Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.

Clinical pharmacology and therapeutics Jun 12, 2019
Generic drug products are approved by the US Food and Drug Administration (FDA) through Abbreviated New Drug Applications (ANDAs). The ANDA review and approval involves multiple offices across the FDA. Forecasting ANDA submissions can critically info...
Drug Approval Drugs, Generic Resource Allocation Time Factors United States United States Food and Drug Administration Humans Machine Learning
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Early access to health products in France: Major advances of the French "Conseil stratégique des industries de santé" (CSIS) to be implemented (modalities, regulations, funding).

Therapie Dec 13, 2018
In a context of perpetual evolution of treatments, access to therapeutic innovation is a major challenge for patients and the various players involved in the procedures of access to medicines. The revolutions in genomic and personalized medicine, art...
Health Care Sector France Health Systems Agencies Humans Clinical Trials as Topic Hospitals Device Approval Diffusion of Innovation Drug Approval
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Classification of nervous system withdrawn and approved drugs with ToxPrint features via machine learning strategies.

Computer methods and programs in biomedicine Feb 9, 2017
BACKGROUND AND OBJECTIVES: Early-phase virtual screening of candidate drug molecules plays a key role in pharmaceutical industry from data mining and machine learning to prevent adverse effects of the drugs. Computational classification methods can d...
Humans Algorithms Patient Safety Computer Simulation Sensitivity and Specificity Benzene Support Vector Machine Carbon Drug Approval Risk Toluene Product Surveillance, Postmarketing Linear Models Area Under Curve Ethylamines Nervous System Pattern Recognition, Automated Drug Monitoring False Positive Reactions Safety-Based Drug Withdrawals Pharmaceutical Preparations Data Mining
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Edoxaban vs warfarin in patients with nonvalvular atrial fibrillation in the US Food and Drug Administration approval population: An analysis from the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial.

American heart journal Dec 1, 2015
BACKGROUND: Edoxaban is a specific anti-Xa inhibitor that, in comparison to warfarin, has been found to be noninferior for the prevention of stroke or systemic embolism (SSE) and to reduce bleeding significantly in patients with nonvalvular atrial fi...
Blood Coagulation Double-Blind Method Warfarin Stroke Pyridines Aged Humans Factor Xa Thrombolytic Therapy Myocardial Infarction Male Female Factor Xa Inhibitors Atrial Fibrillation United States Anticoagulants Drug Approval United States Food and Drug Administration Dose-Response Relationship, Drug Thiazoles
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A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

Clinical pharmacology and therapeutics Sep 24, 2015
We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology dr...
Neoplasms Antineoplastic Agents Clinical Trials, Phase II as Topic Drug Approval Machine Learning Algorithms Forecasting Humans
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Drug repurposing to identify potential FDA-approved drugs targeting three main angiogenesis receptors through a deep learning framework.

Molecular diversity Aug 1, 2025
Tumor cell survival depends on the presence of oxygen and nutrients provided by existing blood vessels, particularly when cancer is in its early stage. Along with tumor growth in the vicinity of blood vessels, malignant cells require more nutrients; ...
Humans Deep Learning United States ErbB Receptors Receptors, Vascular Endothelial Growth Factor Receptors, Fibroblast Growth Factor Angiogenesis Angiogenesis Inhibitors Drug Repositioning United States Food and Drug Administration Drug Approval
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Repurposing FDA-approved drugs as NLRP3 inhibitors against inflammatory diseases: machine learning and molecular simulation approaches.

Journal of biomolecular structure & dynamics May 1, 2025
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...
Drug Repositioning Molecular Docking Simulation NLR Family, Pyrin Domain-Containing 3 Protein Humans Protein Binding Molecular Dynamics Simulation United States Food and Drug Administration Inflammation Inflammasomes Machine Learning Drug Approval United States
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[Not Available].

Recenti progressi in medicina Dec 1, 2024
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...
National Health Programs Algorithms Databases, Factual Italy Drug Approval Humans Artificial Intelligence
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Hunting for New Drugs with AI.

Nature Dec 1, 2019
Machine Learning Male Drug Design Drug Discovery Humans Artificial Intelligence United States Food and Drug Administration Drug Industry Cytochrome P-450 Enzyme System Drug Approval United States Parkinson Disease Prostatic Neoplasms Drug-Related Side Effects and Adverse Reactions Cytochrome P-450 Enzyme Inhibitors
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Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2.

JCO clinical cancer informatics Sep 1, 2019
PURPOSE: Drug development in oncology currently is facing a conjunction of an increasing number of antineoplastic agents (ANAs) candidate for phase I clinical trials (P1CTs) and an important attrition rate for final approval. We aimed to develop a ma...
Drug Approval Clinical Trials, Phase I as Topic Machine Learning Algorithms Reproducibility of Results Antineoplastic Agents United States United States Food and Drug Administration Medical Oncology Medical Informatics Humans
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