Rationalizing the Preclinical-Clinical Hurdle – How to Overcome the Toxicology Exposure Challenge
26 March 2024This webinar will explore navigating the preclinical to clinical transitions with a focus on addressing toxicology exposure challenges.
Join our speakers Andrew Parker and Valeria Ciarnelli as we delve into regulatory framework and the needs of enabling technologies for poorly soluble molecules.
In this presentation, Dr. Valeria Ciarnelli, Senior Director of Product Development, and Dr. Andrew Parker, Senior Drug Development Consultant, will discuss considerations when navigating the pre-clinical to clinical transition, delving into the regulatory expectations and the needs of enabling technologies for poorly soluble molecules, among other topics.
Our speakers will review the solutions that our team have developed to help customers successfully navigate through development milestones, leveraging the Quotient Sciences Translational Pharmaceutics® platform. They will share rationale for assessing amorphous solid dispersions when compared with lipidics and size reduction, and show how these can be easily translated into fit-for-purpose, first-in-human (FIH) presentations suitable for oral administration and enabling dose escalation.
Key learning objectives:
- How to identify the best development strategy, technology(s) and candidate(s), demonstrate solubility improvement and stability.
- Justify selection of prototypes as being suitable for testing in animals and potentially improving exposure to meet toxicology multiples required to justify entering a FIH study.
- Where to invest from early stage, modularity of the preclinical screen and how it can be refined based on your needs.