Submitting an Investigational New Drug (IND) application is a pivotal step in the drug development pathway. It provides proof-of-concept and preclinical safety data as it moves toward First-In-Human (FIH) studies. Success requires a strategic bioanalytical approach with clear objectives to deliver reliable human exposure data, target engagement, pathway modulation, early pharmacodynamic (PD) signals, and potential immunogenicity risk assessment.
Read our article, where we highlight important IND-enabling factors, including:
- Bioanalytical considerations for IND-enabling and FIH studies, including modality-specific examples with best practices and recommendations
- Defining bioanalytical goals, the regulatory landscape, compliance, and considerations influencing assay selection, validation, and execution
- Biomarker and PD strategy selection, focusing on translational relevance and fit-for-purpose assay design
- Strategic study design elements integrating bioanalytical data into clinical decision-making
