Whats the goal of preclinical
To determine if a compound is safe for initial use in humans and to evaluate whether the pharmacological activity supports commercial development
When is an IND submitted
Most commonly in phase 1 or phase 2. before studying in humans however could even happen at phase 3.
What is form 1571
Every IND is accompanied by this administrative cover sheet; it included: details of the sponsor, product name, proposed indications of use, and submission contents
Form 1572
FDA must be notified of all investigators participating in the clinical trial. They must sign this investigator statement containing all necessary details.
IRB
Institutional review board
Form FDA 3674
A certification of compliance with requirements of clinical trials dot gov. A national clinical trial NCT # has been obtained. This form accompanies the submission of a new protocol.
IND content must include 21 CFR 312.23
Animal Pharmacology & Toxicology
Manufacturing Information
Clinical Protocols & Investigator Info
Ipsp
Initial Pediatric Study Plan
SAD
Single ascending dose
DDI
Drug drug interaction
