一直以来，肿瘤药物的剂量策略都以最大耐受剂量为重点。这导致药物的药代动力学（PK）特征、药代动力学/药效学（PK/PD）关系以及临床靶点抑制作用在很大程度上被忽视。Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. What’s more, for many oncology drugs, their dosing or schedules have been modified to address safety or tolerability issues after regulatory approval.
These challenges spurred the FDA’s Oncology Center of Excellence to develop a new guidance called “Project Optimus” to addresses issues relating to dose optimization in clinical trials assessing the safety and efficacy of oncology drugs.
What does this shift in dose optimization during drug development mean for the small biotechs that develop more than 80% of novel compounds? And what steps should they take regarding their upcoming clinical trials?
During this webinar, Certara’s Dr. Julie Bullock will address:
- How Project Optimus may impact clinical trials in the oncology space
- How the guidance may affect the current oncology drug pipeline
- Whether it may lead to the FDA making other changes in the oncology clinical trial space
