syring 发表于 2025-3-25 05:42:45
Dose Optimization of Oncology Drugs: A Clinical and Regulatory Perspectiveluding leukemia 2023, kidney cancer, and melanoma (Siegel, CA Cancer J Clin 73(1):17–48, 2023). The development of targeted therapies, in particular, has dramatically altered the therapeutic landscape and improved outcomes for patients. Despite the seismic changes that have occurred in the field, so包租车船 发表于 2025-3-25 10:15:56
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Novel Oncology Dose-Finding Designs for the New Millenniume treatments, oncology trials need to start human research at a lower dose level and then move up and down through some dose levels in a process called dose finding that helps determine a safe dose level. The toxicity of these oncology drugs is always assumed to increase with dose. However, unlike idictator 发表于 2025-3-25 16:56:48
Practical Guidance on Oncology Dose Escalation Designshe dose limiting toxicity (DLT) data have been widely implemented in real clinical trials, including rule-based designs (e.g., i3+3), model-based designs (e.g., CRM and BLRM) and model-assisted designs (e.g., mTPI, mTPI-2, and BOIN). In this chapter, we have a brief review of popular novel designs,COKE 发表于 2025-3-25 21:20:55
Monotonic Dose–Response and Curve-Free Designs for Phase I Dose-Finding Trialsed designs typically use parametric models to facilitate the exchange of information across dose levels, curve-free designs rely solely on the monotonic assumption to extrapolate data between doses. In the first part of this chapter, we present several curve-free designs for phase I trials that were兴奋过度 发表于 2025-3-26 02:36:42
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Patient-Reported Tolerability in Oncology Drug DevelopmentThere is a growing understanding of and encouragement for the use of PROs to capture tolerability. Traditionally, tolerability has been defined as the absence of serious adverse events. More recent and patient-centric definitions of tolerability have been put forward, focusing on how patients feel aCommission 发表于 2025-3-26 17:21:51
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