FDA General

Integrative Genomic and Clinical Profiling of Colorectal Cancer Liver Metastases to Guide Personalized Surgery and Liver Transplantation.

BACKGROUND/AIM: Colorectal cancer liver metastases (CRLM) remain a leading cause of cancer-related mortality. Although hepatic resection is the only established curative option, recurrence exceeds 60%, underscoring substantial biologic heterogeneity. Liver transplantation (LT) has re-emerged for highly selected patients with unresectable CRLM, but optimal biologic selection criteria remain undefin...

Can heavy metal accumulation in crops be mitigated by microbial inoculants? A meta-analysis and machine learning.

"Hidden hunger" and heavy metal contamination in agricultural products pose critical challenges to agricultural security, with microbial inoculants offering a potential pathway for synergistic mitigation. This study conducted a systematic meta-analysis from 442 studies, exploring the regulation and mechanisms of microbial inoculants on crop essential and toxic heavy metal contents. Results indicat...

Teaching AI ethics in medical schools: a scoping review protocol on the ethical-technical balance in curricular frameworks.

INTRODUCTION: The rapid integration of artificial intelligence (AI) technologies in healthcare, ranging from diagnostic tools to clinical decision sup...

Integrating Machine Learning and Single-Cell Analysis to Reveal the Diagnostic and Therapeutic Value of Regulated Cell Death Mechanisms in Hepatocellular Carcinoma.

Hepatocellular carcinoma (HCC) treatment faces significant challenges, particularly in tumor growth, metastasis, and drug resistance. While several pr...

Artificial intelligence (AI)-aided clinical data management: Applications, human-in-the-loop workflows, and regulatory considerations.

Clinical data management (CDM) is central to the quality of clinical research. In Japan, CDM faces a shortage of qualified personnel, particularly in ...

Japanese regulation and approval process for medical artificial intelligence (AI) as software as a medical device (SaMD): Current status and emerging challenges.

The rapid expansion of artificial intelligence (AI) in healthcare has led to increasing adoption of AI-based software as a medical device (SaMD). This...

Artificial intelligence (AI)-assisted diagnosis of skin diseases: From image classification to dermatology-specific multimodal clinical reasoning.

Artificial intelligence (AI) in dermatology has moved beyond the early paradigm of single-image classification. Dermatological diagnosis is achieved b...

Clinical artificial intelligence (AI) in Japan: Regulatory pathways, domain-specific evidence, and its data infrastructure from an international perspective.

Artificial intelligence (AI) has advanced rapidly across clinical domains, generating both a growing evidence base and dedicated regulatory frameworks...

Human-in-the-loop reconsidered: Shadow use and reliance management in drug development.

This article examines the ethical governance of artificial intelligence (AI) use in drug development through joint principles of good AI practice issu...

Exploring the operational challenges of navigating ethical oversight in the era of artificial intelligence: a qualitative study of health research ethics committees in Tanzania.

BACKGROUND: Health Research Ethics Committees (HRECs) play a pivotal role in safeguarding research participants and ensuring ethical conduct. The rapi...

From Data to Decision: Standardization, Validation, and Regulatory Readiness of AI-Driven Analytical Chemistry Workflows.

Artificial intelligence (AI) is fundamentally reshaping analytical chemistry by enabling automated data interpretation, intelligent method optimizatio...

Artificial intelligence and multi-omics revealed the authentic regulation of ADP-ribosylation in modulation Treg/Th17 ecosystem and multi-target therapeutic strategy enrichment for HBV+ Hepatocellular Carcinoma patients.

OBJECTIVE: Dysregulation of Protein post-translation(PTM) and Treg/Th17 balance contribute to the progression of Hepatocellular Carcinoma(HCC) patient...

AmesNet: A Task-Conditioned Deep Learning Model with Enhanced Sensitivity and Generalization in Ames Mutagenicity Prediction.

Regulatory agencies require comprehensive genotoxicity assessments for novel small-molecule therapeutics prior to human trials. Developers often delay...

Evaluation of a Digital Intervention for Monitoring and Improving Medication Adherence Among Real-World e-Consumers of HIV Preexposure Prophylaxis in China: Protocol for a Randomized Controlled Trial.

BACKGROUND: Preexposure prophylaxis (PrEP) is a key biomedical HIV prevention strategy that relies heavily on adherence for optimal effectiveness. In ...

Integrating Machine Learning and Pharmacology Reveals NF-κB-Mediated Inflammatory Regulation by Shuanghuanglian Injection in Acute Lung Injury.

ETHNOPHARMACOLOGICAL RELEVANCE: Shuanghuanglian Injection (SHLI) is a traditional Chinese medicine formulation derived from Lonicerae Japonicae Flos, ...

Moving artificial intelligence from research to real-world clinical use in neurology.

Artificial intelligence (AI) applications in neurology have reached an inflection point. Despite US Food and Drug Administration approval of numerous ...

Mapping the intellectual landscape of malaria drug repurposing: a systematic analysis of the 51 most cited studies.

BACKGROUND: The escalating threat of Plasmodium falciparum resistance to artemisinin-based therapies necessitates accelerated drug development. Drug r...

Artificial Intelligence in Gynecologic Oncology: Current Applications, Clinical Challenges, and Future Perspectives.

Cervical, endometrial, ovarian, vulvar, vaginal, fallopian tube, and gestational trophoblastic neoplasia (GTN) are major gynecologic cancers that sign...

Comparative diagnostic accuracy of image-enhanced endoscopy modalities and artificial intelligence-assisted endoscopy for gastric intestinal metaplasia and gastric dysplasia: protocol for a systematic review and diagnostic test network meta-analysis.

INTRODUCTION: Gastric intestinal metaplasia (GIM) and gastric dysplasia are critical precursors in the Correa cascade of gastric carcinogenesis. Altho...

Unsupervised Machine Learning of Inflammatory Bowel Disease Case Reports Reveals Decades of Evolving Research Themes.

BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) case reports provide rich longitudinal insights but have rarely been analyzed using quantitative...