ReviewNature reviews. Drug discovery2025
Application of new approach methodologies for nonclinical safety assessment of drug candidates.
Review in Nature reviews. Drug discovery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis 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, 1 synthesis or guideline pooled it.
- Nanomaterials targeting ferroptosis for osteoarthritis treatment: a systematic review of preclinical evidence.Journal of nanobiotechnology · 2026Pooled it
- From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs.Clinical pharmacology and therapeutics · 2026Review
- Systems biology framework for the rational design of operational conditions for in vitro/in vivo translation of tissue models.Science advances · 2026Article
- Construction and evaluation of an independently generated transgenic mouse model carrying mutated human HRAS genes for short-term carcinogenicity assessment.Transgenic research · 2026Article
- Assessing drug-induced liver injury liabilities in human and animal hepatocytes under static and perfused spheroid culture conditions.Toxicological sciences : an official journal of the Society of Toxicology · 2026Article
- Induced pluripotent stem cells from discovery to translation.Nature medicine · 2026Review
- Therapeutic Insights into the Hepatoprotective Effect of Strobilanthes callosa.Cell biochemistry and biophysics · 2026Article
- Emerging organoids and organoids-on-chip platforms for translational development of antibody‒drug conjugates and next-generation bioconjugates.Acta pharmaceutica Sinica. B · 2026Review
- Organoids-on-a-Chip: An Integrating New Technology for Drug Development.International journal of molecular sciences · 2026Review
- Discovery of novel anti-RSC advances · 2026Article
- Mechanical and structural responses of silk fibroin scaffolds to MechanoCulture T6® bioreactor loading and enzymatic degradation.Journal of the mechanical behavior of biomedical materials · 2026Article
- Model-Informed Decision Making from Drug Discovery to Reimbursement: A Roadmap for Clinical Pharmacology in Value-Based Healthcare.Journal of clinical pharmacology · 2026Review
- Enhancement of Gut Microbial Homeostasis by a Post-NGPNutrients · 2026Article
- Review
- Selective Targeting of Immune Checkpoints HLA-G and CD47 Using Novel Dual Signaling Protein DSP216 Promotes Innate Anticancer Immunity.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- New Frontiers of Drug Development Through the Use of New Approach Methodologies.The AAPS journal · 2026Review
- Organoids in cancer therapy: translational applications and clinical promise.Molecular cancer · 2026Review
- Cellular Snowballing: Cell Adhesion and Migration Drive the Self-Assembly of Cell-Microgel Biohybrid Spheroids.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Physiologically relevant 3D CRISPR screening enhances mechanistic insight into chemical toxicity compared to 2D screening.Toxicology · 2026Article
- Illuminating the path to oncolysis: rise of microbial phototherapy.Journal of nanobiotechnology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The development of new approach methodologies (NAMs) and advances with in vitro testing systems have prompted revisions in regulatory guidelines and inspired dedicated in vitro/ex vivo studies for nonclinical safety assessment. This Review by a safety reflection initiative subgroup of the European Federation of Pharmaceutical Industries and Associations (EFPIA)/Preclinical Development Expert Group (PDEG) summarizes the current state and potential application of in vitro studies using human-derived material for safety assessment in drug development. It focuses on case studies from recent projects in which animal models alone proved to be limited or inadequate for safety testing. It further highlights four categories of drug candidates for which alternative in vitro approaches are applicable and discusses progress in using in vitro testing solutions for safety assessment in these categories. Finally, the article highlights new risk assessment strategies, initiatives and consortia promoting the advancement of NAMs. This collective work is meant to encourage the use of NAMs for more human-relevant safety assessment, which should ultimately result in reduced animal testing for drug development.
Indexed as
Identifiers
40316753What 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.