FDA General

Artificial intelligence algorithm optimization and application in patient-based real-time quality control (PBRTQC).

Patient-based real-time quality control (PBRTQC) serves as a vital supplement to quality management in clinical laboratories. Its core principle is to monitor the testing process in real time and continuously through patient test data. As artificial intelligence (AI) technology develops rapidly, AI has provided novel pathways for the innovation of PBRTQC algorithms and drives its transition from a...

Applications and Challenges of Artificial Intelligence and Big Data in Drug Regulation.

Artificial intelligence (AI) and big data are increasingly applied in drug regulation and have demonstrated significant potential worldwide. The U.S. Food and Drug Administration (FDA) has developed a relatively comprehensive approach through strategic frameworks, regulatory guidelines, and pilot programs. The European Medicines Agency (EMA) has promoted AI adoption via the Big Data Task Force, DA...

Treehopper-Inspired Passive Electroluminescent Vector Electric Field Sensor with Deep Learning-Enabled High-Precision Reconstruction.

Electric fields are fundamental physical quantities that describe electromagnetic phenomena. Achieving passive, high-precision, vector-resolved sensin...

In vivo quantification of arterial active mechanics using deep learning-assisted pressure-area analysis.

Active arterial mechanics, governed by vascular smooth muscle contraction, are critical to physiological regulation, cardiovascular disease progressio...

Speech-to-Speech Voice-Cloning Care (SVCC) for improving ICU-acquired anxiety for critically ill patients in a tertiary hospital in Beijing, China: protocol of a randomised, controlled trial.

INTRODUCTION: Intensive care unit (ICU) visiting restrictions in hospitals, implemented due to infection control and other factors, limited contact be...

A deep-learning-based early warning system for abnormal eye conditions in chickens.

In current poultry production practice, farmers are required to frequently enter their poultry houses and visually inspect their chickens to assess fl...

Autonomic and resting-state effective connectivity signatures of binge eating behavior.

Autonomic dysfunction, measured by heart rate variability (HRV) is implicated in the manifestation of binge eating (BE) behaviors. Aberrant resting-st...

An AI-based approach accelerates the discovery of protein-protein interaction modulators targeting NCS-1.

Drug repurposing is an efficient strategy to accelerate the identification of therapeutic compounds by finding new uses for existing drugs. Here, we l...

Performance validation of an artificial intelligence-assisted chest radiograph algorithm for incidental pulmonary nodule detection in Malaysian healthcare facilities: a multicentre cross-sectional study protocol.

INTRODUCTION: Incidental pulmonary nodules (IPNs) are commonly encountered on chest radiographs (CXRs) performed for routine clinical indications and ...

Di-(2-ethylhexyl) terephthalate promotes breast cancer progression: Multi-omics integrated experimental validation.

Di-(2-ethylhexyl) terephthalate (DOTP), as an alternative to phthalate plasticizers, has been widely used in sensitive fields such as food packaging a...

Adolescents Experiencing Both Bullying and Childhood Trauma: Longitudinal Patterns, Psychosocial Networks, and Risk Prediction.

Adolescents who experience both bullying at school and maltreatment within families are at heightened risk for psychological harm, yet little is known...

Machine Learning for Estimating Cardiorespiratory Fitness in Patients With Obesity: Protocol for a Retrospective and Prospective Multicenter Cohort Study.

BACKGROUND: Cardiorespiratory fitness (CRF) is a key predictor of cardiovascular and other health-related diseases in individuals with obesity. CRF is...

MTCL2 is essential for the bipolar-to-multipolar transition in the dendrite extension of cerebellar granule neurons.

The dynamic regulation of neuronal polarity is essential for the formation of neural networks during brain development. Primary cultures of rodent neu...

Nano-antimicrobial peptides (Nano-AMPs) to combat resistant gram-negative bacteria.

The emergence of antimicrobial resistance (AMR) poses a critical threat to public health worldwide, making conventional antibiotics ineffective agains...

Developing a Metabolic-Associated Prognostic Index for Risk Stratification and Therapeutic Guidance in Stage I Lung Adenocarcinoma via Multiomics Analysis.

PURPOSE: Early-stage lung adenocarcinoma (LUAD) exhibits substantial clinical heterogeneity that is not fully explained by TNM staging, highlighting t...

Optimization of drug diffusion in drug-eluting stents for coronary artery based on deep reinforcement learning.

Drug-eluting stents (DES) are extensively used to treat coronary artery disease, and improving their therapeutic efficacy remains a long-standing rese...

Adverse reactions of PD-1/PD-L1 inhibitors in cancer: FAERS database analysis and protocols to mitigate immune-related events in elderly patients and when using pembrolizumab and atezolizumab.

OBJECTIVE: This study aimed to characterize adverse drug reactions (ADRs) associated with programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) in...

Artificial Intelligence in Coronary Computed Tomography: Current Applications, Future Potentials, and Real-world Challenges.

Artificial intelligence (AI) is rapidly transforming cardiac computed tomography (CT) imaging by enhancing image acquisition, reconstruction, and anal...

Retrieval Augmented Generation (RAG) for Evaluating Regulatory Compliance of Drug Information and Clinical Trial Protocols.

The purpose was to evaluate retrieval-augmented generative (RAG) artificial intelligence (AI) methods for assessing the regulatory compliance of drug ...

Deep Learning Models for Shelf Life Prediction and Regulation of Various Foods: A Systematic Review.

Accurate prediction of food shelf life is critical for ensuring food safety, reducing waste, and delivering reliable products to consumers. Deep learn...