Preferred Label : Exploratory Investigational New Drug Study;
NCIt synonyms : Exploratory IND Study; Exploratory Investigational New Drug Trial;
NCIt definition : A type of clinical trial that involves low dosage and short duration of drug exposure
for a limited number of study participants with the intent of gathering preliminary
data on the mechanism of action, pharmacodynamics, pharmacokinetics, or bioavailability
of promising therapeutic candidate agents in human subjects.;
Alternative definition : CDISC-GLOSS: A clinical study that is conducted early in Phase 1; involves very limited
human exposure and has no therapeutic or diagnostic intent (e.g., screening studies,
microdose studies) [FDA Guidance for industry, investigators, and Reviewers: exploratory
IND studies, January 2006] See also Phase 0.;
NCI Metathesaurus CUI : CL540488;
Origin ID : C142547;
UMLS CUI : C4684663;
Semantic type(s)
- concept_is_in_subset
