Table 2 IND application table of contents
From: The basics of preclinical drug development for neurodegenerative disease indications
1 | Form FDA 1571 | [21 CFR 312.23(a)(1)] |
2 | Table of contents | [21 CFR 312.23(a)(2)] |
3 | Introductory statement | [21 CFR 312.23(a)(3)] |
4 | General investigational plan | [21 CFR 312.23(a)(3)] |
5 | Investigator's brochure | [21 CFR 312.23(a)(5)] |
6 | Protocol(s) | [21 CFR 312.23(a)(6)] |
|  |    a. Study protocols | [21 CFR 312.23(a)(6)] |
|  |    b. Investigator data | [21 CFR 312.23(a)(6)(iii)(b)]a |
|  |    c. Institutional review board data | [21 CFR 312.23(a)(6)(iii)(b)]a |
7 | Chemistry, manufacturing, and control data | [21 CFR 312.23(a)(7)] |
8 | Pharmacology and toxicology data | [21 CFR 312.23(a)(8)] |
9 | Previous human experience | [21 CFR 312.23(a)(8)] |
10 | Additional information | [21 CFR 312.23(a)(10)] |