ReviewNature reviews. Drug discovery2020
Phase 0/microdosing approaches: time for mainstream application in drug development?
Review in Nature reviews. Drug discovery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 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
56 citing papers in PubMed.
- Dose Optimization of rhIL-7-hyFc for Patients With Lymphopenia Using a Neonatal Fc Receptor-Mediated Recycling-Based and Target-Mediated Drug Disposition Pharmacokinetic Model.Clinical and translational science · 2025Trial
- ACD856, a novel positive allosteric modulator of Trk receptors, single ascending doses in healthy subjects: Safety and pharmacokinetics.European journal of clinical pharmacology · 2024Trial
- Detailed pharmacokinetic features of a novel bis-boronEuropean journal of nuclear medicine and molecular imaging · 2026Article
- Intramedullary injection of polymerized laminin in acute traumatic spinal cord injury: a first-in-human pilot study.Spinal cord · 2026Article
- Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026Review
- PK and PK/PD Modeling of Bcl2 Inhibitor S65487 in Patients With AML and Investigation of Nonlinearity With Microdosing.CPT: pharmacometrics & systems pharmacology · 2026Article
- Evaluating "brain permeability": A critical issue for the development of therapeutic agents for primary and metastatic brain tumors.Neuro-oncology · 2026Review
- Impact of Preclinical Verification in Physiologically Based Pharmacokinetic Modelling for First-in-Human Predictions: Application of a Published Model Building Strategy for Five Compounds.Clinical pharmacokinetics · 2026Article
- Multi-omics liquid biopsy identifies mitochondrial dysfunction in geographic atrophy and supports the longevity-associated metabolite α-ketoglutarate as a therapeutic strategy.medRxiv : the preprint server for health sciences · 2026Article
- The impact of microdosed plyometric training on speed and explosive abilities of football players during the pre-season.BMC sports science, medicine & rehabilitation · 2026Article
- Bridging the gap: meta-epidemiological analysis on the clinical translation of stem cell-based therapies in women's reproductive diseases.Human reproduction open · 2026Article
- Comparing three methodologies for network analysis of human [EJNMMI research · 2025Article
- Simultaneous Target-Mediated Drug Disposition-Pharmacodynamic (TMDD-PD) Modeling of Finasteride and Dutasteride: Impact of Target Binding and Turnover on Non-linear Pharmacokinetics.The AAPS journal · 2025Article
- New Approach Methodologies: What Clinical Pharmacologists Should Prepare For.Clinical pharmacology and therapeutics · 2025Article
- Modeling Whole-Body Dynamic PET Microdosing Data to Predict the Whole-Body Pharmacokinetics of Glyburide in Humans.Clinical pharmacokinetics · 2025Article
- Evaluation of dose linearity in the systemic availability and pharmacokinetics of topically administered diclofenac: ADrug metabolism and disposition: the biological fate of chemicals · 2025Article
- Effective Therapeutic Strategies to Prevent Frailty and Falls in Community-Dwelling Older Adults.Aging and disease · 2025Review
- The 3C (Cell Culture, Computer Simulation, Clinical Trial) Solution for Optimizing the 3R (Replace, Reduction, Refine) Framework during Preclinical Research Involving Laboratory Animals.ACS pharmacology & translational science · 2025Review
- Advances in PET Imaging of α7 Nicotinic Receptors: From Radioligand Development to CNS Applications.Basic & clinical pharmacology & toxicology · 2025Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Phase 0 approaches - which include microdosing - evaluate subtherapeutic exposures of new drugs in first-in-human studies known as exploratory clinical trials. Recent progress extends phase 0 benefits beyond assessment of pharmacokinetics to include understanding of mechanism of action and pharmacodynamics. Phase 0 approaches have the potential to improve preclinical candidate selection and enable safer, cheaper, quicker and more informed developmental decisions. Here, we discuss phase 0 methods and applications, highlight their advantages over traditional strategies and address concerns related to extrapolation and developmental timelines. Although challenges remain, we propose that phase 0 approaches be at least considered for application in most drug development scenarios.
Indexed as
Identifiers
32901140What Socratic 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 Socratic graph.