ReviewFrontiers in pharmacology2024
The application of Phase 0 and microtracer approaches in early clinical development: past, present, and future.
Review in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
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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.
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Who cites it
5 citing papers in PubMed.
- 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
- A Phase 1 Oral Mass Balance and Combined Intravenous [Journal of clinical pharmacology · 2026Article
- Inductively coupled plasma mass spectrometry as a sensitive non-radioactive alternative for quantitative analysis in drug metabolism studies based on fluorine detection.Analytical and bioanalytical chemistry · 2026Article
- The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology.Pharmaceutical research · 2025Review
- Engineered nanofiber scaffolds prime chromatin reorganization to sensitize cells for long-term and low-dose chemical hazard detection.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Phase 0 microdosing studies were introduced to the drug development community approximately 20 years ago. A microdose is defined as less than 1/100th of the dose calculated based on animal data to yield a pharmacological effect in humans, with a maximum of 100 μg, or 30 nmoles for protein products. In our experience, Phase 0 microdose studies have not been fully embraced by the pharmaceutical industry. This notion is based on the number of Phase 0 studies that we have been involved in. Thus, we conducted at least 17 Phase 0 microdose studies in the Zero's (on average, two per year), but in the years beyond this, it was only 15 studies (1.4 per year); in these latter years, we did conduct a total of 23 studies which employed an intravenous (i.v.) microdose for absolute bioavailability (ABA) assessments (two per year on average), which are the most used and potentially informative type of clinical study using a microdose, albeit they are formally not microdose studies. In the current review, we summarize the past use of and experience with Phase 0 microdose designs in early clinical development, including intravenous
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