FDA General

APOLLO 11 Project, Consortium in Advanced Lung Cancer Patients Treated With Innovative Therapies: Integration of Real-World Data and Translational Research.

INTRODUCTION: Despite several therapeutic efforts, lung cancer remains a highly lethal disease. Novel therapeutic approaches encompass immune-checkpoint inhibitors, targeted therapeutics and antibody-drug conjugates, with different results. Several studies have been aimed at identifying biomarkers able to predict benefit from these therapies and create a prediction model of response, despite this ...

Machine learning models to predict ligand binding affinity for the orexin 1 receptor.

The orexin 1 receptor (OX1R) is a G-protein coupled receptor that regulates a variety of physiological processes through interactions with the neuropeptides orexin A and B. Selective OX1R antagonists exhibit therapeutic effects in preclinical models of several behavioral disorders, including drug seeking and overeating. However, currently there are no selective OX1R antagonists approved for clinic...

Microsatellite Instability, Mismatch Repair, and Tumor Mutation Burden in Lung Cancer.

Since US Food and Drug Administration approval of programmed death ligand 1 (PD-L1) as the first companion diagnostic for immune checkpoint inhibitors...

Combination Therapy-Based Adaptive Control for Organism Using Medicine Dosage Regulation Mechanism.

In this article, the optimal control strategy for organism is investigated by using the adaptive dynamic programming (ADP) method under the architectu...

Validating the Health Benefits of Coffee Berry Pulp Extracts in Mice with High-Fat Diet-Induced Obesity and Diabetes.

The effects of coffee ( L.) berry pulp extracts (CBP extracts) on the improvement of diabetes, obesity, and non-alcoholic fatty liver disease (NAFLD) ...

Deep learning-based tools to distinguish plan-specific from generic deviations in EPID-based in vivo dosimetry.

BACKGROUND: Dose distributions calculated with electronic portal imaging device (EPID)-based in vivo dosimetry (EIVD) differ from planned dose distrib...

Use of Artificial Intelligence to Improve the Calculation of Percent Adhesion for Transdermal and Topical Delivery Systems.

Adhesion is a critical quality attribute and performance characteristic for transdermal and topical delivery systems (TDS). Regulatory agencies recomm...

Deep Learning Augmented Osteoarthritis Grading Standardization.

Manual grading of cartilage histology images for investigating the extent and severity of osteoarthritis (OA) involves critical examination of the cel...

Deep Learning-Based Visual Complexity Analysis of Electroencephalography Time-Frequency Images: Can It Localize the Epileptogenic Zone in the Brain?

In drug-resistant epilepsy, a visual inspection of intracranial electroencephalography (iEEG) signals is often needed to localize the epileptogenic zo...

Considerations and targeted approaches to identifying bad actors in exposure mixtures.

Variable importance is a key statistical issue in exposure mixtures, as it allows a ranking of exposures as potential targets for intervention, and he...

Using Histologic Image Analysis to Understand Biophysical Regulations of Epithelial Cell Morphology.

Epithelial mechanics and mechanobiology have become 2 important research fields in life sciences and bioengineering. These fields investigate how phys...

Comprehensive stiffness regulation on multi-section snake robot with considering the parasite motion and friction effects.

Snake robots have been widely used in challenging environments, such as confined spaces. However, most existing snake robots with large length/diamete...

An Uncertainty-Guided Deep Learning Method Facilitates Rapid Screening of CYP3A4 Inhibitors.

Cytochrome P450 3A4 (CYP3A4), a prominent member of the P450 enzyme superfamily, plays a crucial role in metabolizing various xenobiotics, including o...

Artificial intelligence / machine-learning tool for post-market surveillance of in vitro diagnostic assays.

The study compares an artificial intelligence technology with traditional manual search of literature databases to assess the accuracy and efficiency ...

Optimizing artificial intelligence in sepsis management: Opportunities in the present and looking closely to the future.

Sepsis remains a major challenge internationally for healthcare systems. Its incidence is rising due to poor public awareness and delays in its recogn...

Combining Feature Selection Techniques and Neurofuzzy Systems for the Prediction of Total Viable Counts in Beef Fillets Using Multispectral Imaging.

In the food industry, quality and safety issues are associated with consumers' health condition. There is a growing interest in applying various nonin...

Drug review process advancement and required manufacturer and contract research oraganization responses.

The United States Senate passed the "FDA Modernization Act 2.0." on September 29, 2022. Although the effectiveness of this Bill, which aims to elimina...

A novel efficient drug repurposing framework through drug-disease association data integration using convolutional neural networks.

Drug repurposing is an exciting field of research toward recognizing a new FDA-approved drug target for the treatment of a specific disease. It has re...

DNABERT-based explainable lncRNA identification in plant genome assemblies.

Long non-coding ribonucleic acids (lncRNAs) have been shown to play an important role in plant gene regulation, involving both epigenetic and transcri...

Anti-inflammatory and antioxidative actions of tacrolimus (FK506) on human microglial HMC3 cell line.

Microglial cells are indispensable for the normal development and functioning of neurons in the central nervous system, where they play a crucial role...