Nonclinical Laboratory Study Law and Legal Definition
Nonclinical laboratory study means “in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article.” [21 CFR 58.3; Title 21-Food And Drugs; Chapter I-Food And Drug Administration, Department Of Health And Human Services; Subchapter A-General; Part 58-Good Laboratory Practice For Nonclinical Laboratory Studies; Subpart A-General Provisions]
Legal Definition list
- Noncash Item
- Noncancellable Life, Health, or Accident Insurance Policy [Internal Revenue]
- Noncancelable Policy
- Noncancelability Clause
- Nonboiler
- Nonclinical Laboratory Study
- Noncombatant Service
- Noncommercial Aviation [Internal Revenue]
- Noncommercial Education Broadcasting Entities
- Noncommercial Educational Broadcast Station
- Noncommercial Licensee [Patents]
