(107) Long-Acting Injectable Dose Prediction: Where Are We Really?

Early dose feasibility assessment is critical for effective decision making and efficient LAI formulation development. Traditional mass balance based approaches do not account for PK complexity of LAI formulations and mechanistic SC PBPK models are insufficiently developed or unvalidated [1,2]. We advocate an approach that employs empirical and semi-mechanistic models to translate LAI release profiles to clinical in vivo performance, enabling early prediction of target PK profiles, feasibility assessment, and definition of a Quality Target Product Profile and design space for development.