1. Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research, Pharmacology/Toxicology: January 2006.
2. Innovation or Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products. Rockville, MD: Food and Drug Administration: March 2004.
3. 21 CFR Part 312.23.
4. Guidance for Industry, ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals. Rockville. MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center of Biologics Evaluation and Research; July 1997.
5. Guidance for Industry, ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals. Rockville, MD: Food and Drug Administration; July 2001.