Resource Planning for a GLP Toxicology Program Supporting FDA IND Submission: A Budget Proposal for a Targeted RAS Pathway Inhibitor

Scientifically appropriate studies and realistic resource planning are essential components of successful IND-enabling development (International Council for Harmonisation, 2009). This proposal outlines an oncology budget plan for a Good Laboratory Practice (GLP) toxicology program for a targeted RAS pathway inhibitor intended for use in the oncology space. The budget includes compound supply, formulation and analytical readiness, dose-range-finding activities, GLP toxicology studies, genetic toxicology, safety pharmacology, bioanalytical support, pathology review, quality assurance activities, and final reporting. The goal is to show how a comprehensive toxicology package can be converted into a realistic budget usable for regulatory planning. These figures are illustrative academic estimates prepared to demonstrate budgeting methodology and do not represent actual vendor quotations.Keywords: GLP toxicology; IND-enabling studies; RAS pathway inhibitor; budget planning; contract research organization; resource allocation; regulatory artificial intelligence