Table 2.

Selected IND Sections Relevant to Preclinical Testing

Section	Topic	Content
3.4	Overview of Preclinical Data	Provide brief overview of pharmacology and toxicology data
8.1	Pharmacodynamics
	8.1.1 Primary pharmacodynamics	Describe mechanism of action and drug activity related to proposed indication
	8.1.2 Secondary pharmacodynamics	Describe any secondary pharmacodynamic activity if there is any
8.2	Safety pharmacology	Describe neurological, cardiovascular, pulmonary, renal, gastrointestinal effects, as well as abuse liability and other related topics
8.3	Pharmacokinetics
	8.3.1 Absorption	Describe how the drug is absorbed through the body after administration (blood, liver, and other organ systems)
	8.3.2 Distribution	Describe how the drug distributes throughout the body once it is absorbed
	8.3.3 Metabolism	Describe the metabolites that are derived from the parent drug
	8.3.4 Excretion	Provide overview on how metabolites from the drug are excreted (timing, identification of metabolites, etc)
8.6	Toxicology	Summarize toxicology studies that were performed; mention any relevant information from pre-IND meetings with the FDA. This section should include a title, key findings, drug formulations, methods, dosing, observations, results, summary, and conclusions