Pharmacology/ Toxicology Review

The pharmacology/toxicology review team is staffed by pharmacologists and toxicologists who evaluate the results of animal testing and attempt to relate animal drug effects to potential effects in humans.

Pharmacology and Drug Distribution (21 CFR 312.23(a)(8)(I)):

This section of the application should contain, if known: 1) a description of the pharmacologic effects and mechanism(s) of action of the drug in animals, and 2) information on the absorption, distribution, metabolism, and excretion of the drug. The regulations do not further describe the presentation of these data, in contrast to the more detailed description of how to submit toxicologic data. A summary report, without individual animal records or individual study results, usually suffices.

To the extent that such studies may be important to address safety issues, or to assist in the evaluation of toxicology data, they may be necessary; however, lack of this potential effectiveness should not generally be a reason for a Phase 1 IND to be placed on clinical hold.

Toxicology Data

Present regulations (21 CFR 312.23(a)(8)(ii)(a)) require an integrated summary of the toxicologic effects of the drug in animals and in vitro. The particular studies needed depend on the nature of the drug and the phase of human investigation. When species specificity, immunogenicity, or other considerations appear to make many or all toxicological models irrelevant, sponsors are encouraged to contact the agency to discuss toxicological testing.