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nonclinical test

Defined in 1 dictionary — U.S. Code

United States Code

21 U.S.C. § 355 — for purposes of this section (2 versions over time)

For purposes of this section, the term “nonclinical test” means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test may include the following:

(1) Cell-based assays.

(2) Organ chips and microphysiological systems.

(3) Computer modeling.

(4) Other nonhuman or human biology-based test methods, such as bioprinting.

(5) Animal tests.