ReviewCommunications medicine2025
Regulating the AI-enabled ecosystem for human therapeutics.
Review in Communications medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed.
- Regulatory Research Priorities for AI Use in the Medicine Lifecycle: A European Perspective with Global Relevance.Clinical pharmacology and therapeutics · 2026Article
- The use of artificial intelligence (AI) in neuropsychiatric drug discovery: current challenges and future directions.Translational psychiatry · 2026Review
- Applications and Challenges of Artificial Intelligence and Big Data in Drug Regulation.Therapeutic innovation & regulatory science · 2026Review
- From Algorithms to Assets: A Comprehensive Review of AI's Role in Preclinical Drug Discovery and the Hurdles to Clinical Translation.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Precision oncology in the age of AI: lessons from AI-driven drug discovery and clinical translation.BJC reports · 2026Review
- Artificial Intelligence and the Transformation of Cell and Gene Therapy Development.Pharmaceutics · 2026Review
- Toward integrated sleep health: multimodal AI in Hang Hao Meng agent.NPJ digital medicine · 2026Review
- Beyond the hype: navigating the real-world applications of artificial intelligence (AI) in healthcare.Medical review (2021) · 2026Review
- Artificial intelligence directed computational protein design: lessons from COVID-19 for pandemic-ready vaccines and antibody therapeutics.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026Review
- Could artificial intelligence gradually replace classical adjuvants?Frontiers in immunology · 2026Review
- Federating AI-related regulations for human therapeutics: an AI-enabled, continuously updating regulatory intelligence system.Frontiers in drug safety and regulation · 2026Article
- Plying potency assays for immunotherapy of solid tumors.Frontiers in immunology · 2026Review
- Closing the loop: human-augmented, mechanistically enhanced AI for proactive management of drug-drug interactions.Frontiers in pharmacology · 2026Article
- Applications of artificial intelligence in drug discovery.Emerging topics in life sciences · 2025Article
- Artificial Intelligence in Small-Molecule Drug Discovery: A Critical Review of Methods, Applications, and Real-World Outcomes.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Challenges and standardisation strategies for sensor-based data collection for digital phenotyping.Communications medicine · 2025Review
- From Sea to Therapy: Marine Biomaterials for Drug Delivery and Wound Healing.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Reimagining drug regulation in the age of AI: a framework for the AI-enabled Ecosystem for Therapeutics.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recent advances in artificial intelligence (AI) tools and techniques can revolutionize the discovery, development, manufacturing, and delivery of new medicines by reducing the time and cost involved. The biopharmaceutical industry is a highly regulated sector where robust regulatory oversight is essential to ensure human therapeutics' quality, efficacy, and safety. This Perspective examines the challenges of regulating AI-driven technologies in drug discovery and development. As AI is anticipated to play an unprecedented role in transforming drug development, the critical question is not whether to regulate these advancements but how to do so effectively. Here, we evaluate current global drug regulatory practices, discuss gaps and unknowns, and provide recommendations on addressing these issues to facilitate effective regulations of AI-driven innovation in the biopharmaceutical industry.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.