Titlebook: Dose Finding and Beyond in Biopharmaceutical Development; Jingjing Ye,Ding-Geng Chen,Joseph C. Cappelleri Book 2025 The Editor(s) (if appl

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Emerging Topics in Dose-Finding and Beyond . revisits the basic principles of dose-finding from the 2006 book. Section . discusses and compares the topic of dose-finding in oncology versus non-oncologic diseases in drug development; as a result, this section also introduces a paradigm shift in oncology drug development. Section . discusses

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Dose Optimization of Oncology Drugs: A Clinical and Regulatory Perspectivention to prioritize optimizing the dosage of oncology drugs in the pre-approval setting, marking a shift away from the standard practice (FDA, Project Optimus. Available via .. Cited 18 Nov 2023, 2023a; Optimizing the dosage of human prescription drugs and biological products for the treatment of on

伪造

FDA’s Project Optimus: The “Paradigm-Shifting” Initiative for Oncology Drug Development of novel approaches recently developed that follow the guiding principles of the initiative, some of which had been accepted by the Agency for implementation in real trials. Some regulatory perspectives with suggested analyses in the optimization data package and practical considerations related to

凹槽

Novel Oncology Dose-Finding Designs for the New Millenniume dose of the study drug that can be used in later-phase trials. The traditional 3+3 design in oncology was used for many years to find the maximum tolerated dose (MTD) for chemotherapies. In recent years, several different model-based, model-assisted, and algorithm-based designs for dose finding ha

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Practical Guidance on Oncology Dose Escalation Designsative analysis in terms of operating characteristics in simulation studies, and provide some recommendations to improve the practice. A new approach to improve the MTD determination by DLT weighting is also presented. Finally, some methods beyond DLT-based dose escalation designs are introduced to h

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A Generalized Rank-Based Inferential Seamless Phase 2/3 Design with Dose Selectioncussed in Li et al. (.. In .. ICSA Book Series in Statistics, pp. 285–299. Springer International Publishing Switzerland (2015)), the combined analysis may cause type I error inflation due to the correlation and dose selection. Sidák adjustment has been proposed to control the overall type I error b

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Comparing MCP-Mod and Ordinal Linear Contrast Test in Dose-Finding Clinical Trials: A Thorough Exami convergence issues. Finally, the performance of MCP-Mod is subject to whether the true dose-response relationship is close to one of the selected candidate models. In contrast, the ordinal linear contrast test (OLCT) (Zhang, A simple and efficient statistical approach for designing an early phase I

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Patient-Reported Tolerability in Oncology Drug Development for early-phase and late-phase trials, will be discussed. Issues that will be covered include dose optimisation in early-phase trials and the specification of tolerability endpoints and hypotheses in late-phase trials. We will also discuss key considerations when measuring tolerability in paediatri

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