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Dose finding and beyond in biopharma...

Ye, Jingjing.

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Dose finding and beyond in biopharmaceutical development

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Dose finding and beyond in biopharmaceutical development/ edited by Jingjing Ye ... [et al.].
其他作者:	Ye, Jingjing.
出版者:	Cham :Springer Nature Switzerland : : 2025.,
面頁冊數:	xvii, 254 p. :ill., digital ;24 cm.
內容註:	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.
Contained By:	Springer Nature eBook
標題:	Drug development. -
電子資源:	https://doi.org/10.1007/978-3-031-67110-4
ISBN:	9783031671104

Dose finding and beyond in biopharmaceutical development
Dose finding and beyond in biopharmaceutical development[electronic resource] /edited by Jingjing Ye ... [et al.]. - Cham :Springer Nature Switzerland :2025. - xvii, 254 p. :ill., digital ;24 cm. - ICSA book series in statistics,2199-0999. - ICSA book series in statistics..

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.

ISBN: 9783031671104

Standard No.: 10.1007/978-3-031-67110-4doiSubjects--Topical Terms:

716904
Drug development.

LC Class. No.: RM301.25

Dewey Class. No.: 615.19

Dose finding and beyond in biopharmaceutical development
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