CFR section

21 CFR 58.120(a)(7): Protocol

PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart G-Protocol for and Conduct of a Nonclinical Laboratory Study

Key facts

Citation 21 CFR 58.120(a)(7)
Section Protocol
Part PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Subpart Subpart G-Protocol for and Conduct of a Nonclinical Laboratory Study
Subchapter 21 CFR A General
Product types cited General
Regulation text (excerpt) (7) A description and/or identification of the diet used in the study as well as solvents, emulsifiers, and/or other materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established…

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