Clinical Pharmacology – Chemical
End-to-End Hot Topic
Efforts on multiple fronts are ongoing to accelerate drug development and ensure that new drugs targeting unmet medical need are provided to patients in the most efficient manner. Pharmacometric approaches can help leverage knowledge acquired at each stage of development to inform the next step and optimize the development strategy. Key questions that can be addressed include go/no go decision, selection of optimal dose and dosing regimen, support of the to-be-marketed formulation, and characterization of clinical pharmacology to support regulatory approval. This session will provide several examples of pharmacometric applications that helped accelerate drug development and support regulatory approval of oncology compounds.