Advancing Topical Formulations with Innovative Preclinical Models

A limited proportion of drug candidates ultimately achieve regulatory approval, often due to challenges such as insufficient efficacy, safety concerns, complex or poorly understood targets, limitations in predictive preclinical models, or commercial viability issues. Given the significant cost and time associated with development, early identification of promising candidates and the implementation of a robust development strategy aligned with current quality standards are critical to improving success rates.

Comprehensive drug characterization and preformulation strategies should be employed to assess drug formulatability. Within this approach different models, whether in-silico/mathematical models or in vitro/ex-vivo can be used to screen between different drugs and drug products to select the candidate with the highest chance of success. A sound formulation development approach with full consideration of the drug, the patient and regulatory pathway should include the appropriate in vitro/ex vivo models to de-risk the program prior to clinical studies.

A robust formulation development approach integrates robust scientific principles, systematic formulation development and innovative preclinical models to facilitate early identification of candidates with poor developability. This enables more informed decision-making and supports the advancement of viable drug candidates while mitigating downstream development risks.