This team is STAFFED BY PHARMACOLOGIST & TOXICOLOGIST In this section of the application should contain, if known: - A DESCRIPTION OF THE PHARMACOLOGIC EFFECTS & MECHANISM OF ACTION OF THE DRUG in animal - Information on the ABSORPTION, DISTRIBUTION, METABOLISM & 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 toxicology data. A SUMMARY REPORT, without individual animal record, or individual study results, usually suffices. An integrated SUMMARY of the TOXICOLOGY 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 consideration appear to make many or all toxicological models irrelevant, sponsors are encouraged to contact the agency to discuss toxicology testing