LEADER 04592nam 22007335 450 001 9910983317403321 005 20250905104422.0 010 $a9783031671104 010 $a3031671104 024 7 $a10.1007/978-3-031-67110-4 035 $a(CKB)36431113800041 035 $a(DE-He213)978-3-031-67110-4 035 $a(MiAaPQ)EBC31743898 035 $a(Au-PeEL)EBL31743898 035 $a(OCoLC)1492952662 035 $a(EXLCZ)9936431113800041 100 $a20241028d2025 u| 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aDose Finding and Beyond in Biopharmaceutical Development /$fedited by Jingjing Ye, Ding-Geng Chen, Wen Zhou, Qiqi Deng, Joseph C. Cappelleri 205 $a1st ed. 2025. 210 1$aCham :$cSpringer Nature Switzerland :$cImprint: Springer,$d2025. 215 $a1 online resource (XVII, 254 p. 43 illus.) 225 1 $aICSA Book Series in Statistics,$x2199-0999 311 08$a9783031671098 311 08$a3031671090 327 $aEmerging 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. 330 $aThis book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development. Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase ? clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase ? confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs. The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development. . 410 0$aICSA Book Series in Statistics,$x2199-0999 606 $aBiometry 606 $aExperimental design 606 $aData mining 606 $aBiostatistics 606 $aDesign of Experiments 606 $aData Mining and Knowledge Discovery 606 $aBiometria$2thub 606 $aDisseny d'experiments$2thub 606 $aMineria de dades$2thub 608 $aLlibres electrònics$2thub 615 0$aBiometry. 615 0$aExperimental design. 615 0$aData mining. 615 14$aBiostatistics. 615 24$aDesign of Experiments. 615 24$aData Mining and Knowledge Discovery. 615 7$aBiometria 615 7$aDisseny d'experiments 615 7$aMineria de dades 676 $a570.15195 702 $aYe$b Jingjing$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aChen$b Ding-Geng$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aZhou$b Wen$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aDeng$b Qiqi$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aCappelleri$b Joseph C$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910983317403321 996 $aDose Finding and Beyond in Biopharmaceutical Development$94316181 997 $aUNINA