ReviewClinical and translational science2016
Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development.
Review in Clinical and translational science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 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
43 citing papers in PubMed.
- Interpretation of Pharmacometabolomics Results: Fingerprint of Drug Exposure or Confounder Effects? Insights from a Urinary Metabolomics Study with Voriconazole in Healthy Participants.International journal of molecular sciences · 2026Trial
- A human microdose study of the antimalarial drug GSK3191607 in healthy volunteers.British journal of clinical pharmacology · 2018Trial
- Intra-Target Microdosing - A Novel Drug Development Approach: Proof of Concept, Safety, and Feasibility Study in Humans.Clinical and translational science · 2017Trial
- Drug-drug interaction of microdose and regular-dose omeprazole with a CYP2C19 inhibitor and inducer.Drug design, development and therapy · 2017Trial
- Trial
- Intraoperative molecular imaging - it's all about advancing surgical decision making and improving dexterity.Zeitschrift fur medizinische Physik · 2026Review
- Advanced herbal self-assembled nanoplatforms: targeted, stimuli-responsive, and precision therapeutics for human diseases.Journal of nanobiotechnology · 2026Review
- Safety, Tolerability, and Gut Microbiota Impact of Sericin-Derived Oligopeptides (SDOs) from Yellow Silk Cocoons in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.Foods (Basel, Switzerland) · 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
- An Interventional Radiology Method for In Situ Assessments of Cancer Drug Response: Preclinical Development, Feasibility, and Safety.Radiology. Imaging cancer · 2025Article
- Systemic Metabolic Alterations Induced by Etodolac in Healthy Individuals.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Imaging Cell Surface Plectin in PDAC Patients - A First-In-Human Phase 0 Study Report.Molecular imaging and biology · 2025Article
- Physiologically Based Pharmacokinetic Model of Tyrosine Kinase Inhibitors to Predict Target Site Penetration, with PET-Guided Verification.CPT: pharmacometrics & systems pharmacology · 2025Article
- Phase 0 trials/ Intra-Target-Microdosing (ITM) and the lung: a review.BMC pulmonary medicine · 2024Review
- Utilizing venous occlusion plethysmography to assess vascular effects: A study with buloxibutid, an angiotensin II type 2 receptor agonist.Clinical and translational science · 2024Article
- The application of Phase 0 and microtracer approaches in early clinical development: past, present, and future.Frontiers in pharmacology · 2024Review
- When to consider intra-target microdosing: physiologically based pharmacokinetic modeling approach to quantitatively identify key factors for observing target engagement.Frontiers in pharmacology · 2024Article
- Alternatives to animal models to study bacterial infections.Folia microbiologica · 2023Review
- A naïve pooled data approach for extrapolation of Phase 0 microdose trials to therapeutic dosing regimens.Clinical and translational science · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A number of drivers and developments suggest that microdosing and other phase 0 applications will experience increased utilization in the near-to-medium future. Increasing costs of drug development and ethical concerns about the risks of exposing humans and animals to novel chemical entities are important drivers in favor of these approaches, and can be expected only to increase in their relevance. An increasing body of research supports the validity of extrapolation from the limited drug exposure of phase 0 approaches to the full, therapeutic exposure, with modeling and simulations capable of extrapolating even non-linear scenarios. An increasing number of applications and design options demonstrate the versatility and flexibility these approaches offer to drug developers including the study of PK, bioavailability, DDI, and mechanistic PD effects. PET microdosing allows study of target localization, PK and receptor binding and occupancy, while Intra-Target Microdosing (ITM) allows study of local therapeutic-level acute PD coupled with systemic microdose-level exposure. Applications in vulnerable populations and extreme environments are attractive due to the unique risks of pharmacotherapy and increasing unmet healthcare needs. All phase 0 approaches depend on the validity of extrapolation from the limited-exposure scenario to the full exposure of therapeutic intent, but in the final analysis the potential for controlled human data to reduce uncertainty about drug properties is bound to be a valuable addition to the drug development process.
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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.