The goal of this workshop will be to review the strategies and challenges related to establishing impurity control strategies in early development, pre proof-of-concept (POC), small-molecule drug candidates. Early development candidates face unique challenges with limited experience with the synthetic route and early formulations. Control strategies need to evolve and react to changing routes, formulations and projected maximum daily dose and duration. Although ICH guidelines do not apply at this stage of development, patient safety is paramount and a consistent approach to impurity control and specifications is critical. There will be a focus on impurity identification and qualification strategies and approaches that have been proposed and accepted.
Appreciate the unique challenges for establishing control strategies for early development candidates.
Define appropriate strategies and specifications for controlling non-mutagenic impurities in both Drug Substances and Drug Products for early development candidates.
Understand approaches to impurity identification and qualification for small molecules prior to proof-of-concept.