The high attrition rate in drug development, driven by factors like poor efficacy, safety, and developability, requires a strategic, early-stage approach to minimize risk and cost. Success depends on a robust development strategy and comprehensive characterization aligned with quality standards.

Key Learning Objectives

• Define the principles of topical formulation development and its role in drug success.
• Evaluate the utility of preclinical models, including in silico, in vitro, and ex vivo models, for formulation optimization and candidate selection.
• Develop a robust and phase-appropriate development package that de-risks a program before clinical studies.

A successful formulation approach uses scientific principles and innovative preclinical models to identify candidates with poor developability early, support informed decision-making, and reduce downstream risk.

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