exploratory IND study

exploratory IND study

A clinical evaluation conducted early in a Phase-1 study, which involves very limited human exposure and has no therapeutic or diagnostic intent—e.g., screening studies, microdose studies.
References in periodicals archive ?
The purposes of this guidance the phase exploratory IND study is intended to describe a clinical trial that;
(1,2) The duration of dosing in an exploratory IND study is expected to be limited (e.g., 7 days).
(8.) Food and Drug Administration, Guidance For Industry, Investigators and Reviewers Exploratory IND Study, CDER, U.S.
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