Search results for: fda pre-ind

By the end of the funding period, projects are expected to achieve milestones that significantly move the compound towards the next phase of drug development (e.g., pre-IND meeting, Investigational New Drug (IND) application). Women-owned and socially or economically disadvantaged small business are encouraged to apply.

(for example FDA's Guidance In Vitro Drug Interaction Studies Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions ) Complete any efficacy studies under rigorous requirements to support clinical dose selections Engage clinician support for TPP and clinical plans IND Enabling Stage Goals: Hold any pre-IND meetings as required Produce materials to enable GLP toxicology studies Complete all required studies for IND and produce reports