ReviewPharmaceuticals (Basel, Switzerland)2025
Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective.
Review in Pharmaceuticals (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses that pooled it.
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
36 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- The role of AI-assisted drug repurposing in neurological disorders: a systematic review of validation strategies, challenges and opportunities.Journal of nanobiotechnology · 2026Pooled it
- Harnessing plant growth-promoting bacteria for nanoparticle biosynthesis: a systematic review of mechanisms, agricultural applications, and biomedical potential.Bioprocess and biosystems engineering · 2026Pooled it
- Can artificial intelligence with multimodal imaging outperform traditional methods in predicting age-related macular degeneration progression? A systematic review and exploratory meta-analysis.BMC medical informatics and decision making · 2025Pooled it
- Artificial intelligence-driven digital twins in Pharma 4.0: transforming smart manufacturing, predictive quality assurance, and personalized drug delivery.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026Review
- End-to-End Intelligent Drug Discovery via a Scalable and Explainable Graph-Transformer Framework.Bioengineering (Basel, Switzerland) · 2026Article
- Smart nanoparticle vaccines integrate nanotechnology artificial intelligence and immunoengineering for precision immunization.Discover nano · 2026Review
- Next-Generation Bionic Sensors for Small Molecule Detection: Integrating Synthetic Biology, Nanomaterials, and Artificial Intelligence.Micromachines · 2026Review
- AI in Drug Discovery: Clinical Failures, Regulatory Reality, and the Validation Crisis Behind the Hype.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Artificial intelligence in drug research and development: a review of methods and applications in drug repurposing.Briefings in bioinformatics · 2026Review
- Building trust in the integration of artificial intelligence into chemical risk assessment: findings from the 2024 ECETOC workshop.Archives of toxicology · 2026Article
- Review
- AI-driven drug-target interaction prediction: current progress, challenges, and future roadmap for precision medicine.Journal of computer-aided molecular design · 2026Review
- Deep learning and object detection methods for scoring cell types within the human buccal cell micronucleus and cytome assays for human biomonitoring.Mutagenesis · 2026Review
- AI-driven nanomedicine for cancer theranostics.Molecular cancer · 2026Review
- [Application and progress of artificial intelligence agents in drug development].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2026Review
- Implementing QbD for Nano-Pharmaceuticals and Complex Formulations to Achieve Predictable and High-Quality Outcomes.AAPS PharmSciTech · 2026Review
- TRAIL of Hope: Bioactive Dietary Component-Driven Carrier-Free Nanoplatforms for Synergistically Enhanced Tumor Multimodal Therapy.International journal of nanomedicine · 2026Review
- Computer-aided drug discovery: historical foundations, practical AI tools, and emerging ethical considerations.Frontiers in pharmacology · 2026Review
- Artificial intelligence in vaccine development: applications, implementation, and future directions.Frontiers in cellular and infection microbiology · 2026Review
- AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Artificial Intelligence (AI) has the disruptive potential to transform patients' lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing. However, it presents significant challenges, ethical concerns, and risks across sectors and societies. AI's rapid advancement has revealed regulatory gaps as existing public policies struggle to keep pace with the challenges posed by these emerging technologies. The term AI itself has become commonplace to argue that greater "human oversight" for "machine intelligence" is needed to harness the power of this revolutionary technology for both potential and risk management, and hence to call for more practical regulatory guidelines, harmonized frameworks, and effective policies to ensure safety, scalability, data privacy, and governance, transparency, and equitable treatment. In this review paper, we employ a holistic multidisciplinary lens to survey the current regulatory landscape with a synopsis of the FDA workshop perspectives on the use of AI in drug and biological product development. We discuss the promises of responsible data-driven AI, challenges and related practices adopted to overcome limitations, and our practical reflections on regulatory oversight. Finally, the paper outlines a path forward and future opportunities for lawful ethical AI. This review highlights the importance of risk-based regulatory oversight, including diverging regulatory views in the field, in reaching a consensus.
Indexed as
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.