CFR section
21 CFR 58.120(a)(8): 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)(8) |
|---|---|
| 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) | (8) Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units, of the test or control article to be administered and the method and frequency of administration. |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.