phase 0 clinical studies

synonym: exploratory investigational new drug
https://doi.org/10.1351/goldbook.12707
Exploratory first-in-human trials that involve microdosing of drug to allow the assessment of pharmacokinetic parameters with limited drug exposure.
Note: These trials have no therapeutic or diagnostic intent but are designed to assist decision making by providing bioavailability, metabolism, and other limited data from a small number of patients.
See also: phase I, phase II, phase III, phase IV
Source:
PAC, 2013, 85, 1725. (Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)) on page 1746 [Terms] [Paper]
Citation: 'phase 0 clinical studies' in IUPAC Compendium of Chemical Terminology, 5th ed. International Union of Pure and Applied Chemistry; 2025. Online version 5.0.0, 2025. https://doi.org/10.1351/goldbook.12707 RIS BibTex EndNote
Div. VIITextXMLJSON