Dose Finding and Beyond in Biopharmaceutical Development
portes grátis
Dose Finding and Beyond in Biopharmaceutical Development
Zhou, Wen; Ye, Jingjing; Deng, Qiqi; Cappelleri, Joseph C.; Chen, Ding-Geng
Springer International Publishing AG
12/2024
254
Dura
9783031671098
Pré-lançamento - envio 15 a 20 dias após a sua edição
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Emerging Topics in Dose-Finding and Beyond.- Understanding FDA Guidance On Dosage Optimization For Oncology Therapies.- FDA Project Optimus: The "Paradigm-Shifting" Initiative for Oncology Drug Development.- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs.- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs.- Monotonic Dose Response Assumption and Curve-Free Designs for Phase I Dose Finding Trials.- Dose Selection with 2-in-1 Design.- A Rank-Based Approach to Improve the Efficiency of Inferential Seamless Phase 2/3 Clinical Trials with Dose Optimization.- Comparing MCP-MOD and Ordinal Linear Contrast Test in Dose Finding Clinical Trials: A Thorough Examination.- Patient-Reported Tolerability in Drug Development.- Endpoint Development and Validation.
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Dose-finding designs;dose response clinical trials;clinical research;drug development;Project Optimus;precision medicine;patient-centered research;patient-reported outcomes
Emerging Topics in Dose-Finding and Beyond.- Understanding FDA Guidance On Dosage Optimization For Oncology Therapies.- FDA Project Optimus: The "Paradigm-Shifting" Initiative for Oncology Drug Development.- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs.- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs.- Monotonic Dose Response Assumption and Curve-Free Designs for Phase I Dose Finding Trials.- Dose Selection with 2-in-1 Design.- A Rank-Based Approach to Improve the Efficiency of Inferential Seamless Phase 2/3 Clinical Trials with Dose Optimization.- Comparing MCP-MOD and Ordinal Linear Contrast Test in Dose Finding Clinical Trials: A Thorough Examination.- Patient-Reported Tolerability in Drug Development.- Endpoint Development and Validation.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
