紀錄類型 : 書目-語言資料,印刷品: 單行本
其他作者 : DiMartino, Jorge,
出版者 : Cham, Switzerland :Springer,2022.
面頁冊數 : 1 online resource.
內容註 : Intro -- Contents -- 1: History of Drug Development for Children with Cancer -- 1.1 Introduction -- 1.2 Initial Progress -- 1.3 Rise of the Cancer Cooperative Groups -- 1.4 Impact of Regulation to Improve Safety and Efficacy Federal Laws Providing a Regulatory Framework for Drug Development in Children -- 1.5 Indications -- 1.6 Summary -- References -- 2: Targeted Small Molecule Drug Discovery -- 2.1 Introduction -- 2.2 Stage Gating -- 2.3 Phenotypic Drug Discovery -- 2.4 Target-Based Drug Discovery: Considerations for Target Selection/Identification
內容註 : 2.5 Target-Based Drug Discovery: Identifying Chemical Starting Points -- 2.6 Hit-to-Lead -- 2.7 Lead Optimization -- 2.8 Candidate Nomination -- References -- 3: An FDA Oncology Perspective of Juvenile Toxicity Studies to Support Pediatric Drug Development -- 3.1 Introduction -- 3.2 Should a JAS Be Considered? -- 3.2.1 ICH S11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines -- 3.2.2 ICH S9: Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers -- 3.3 Dinutuximab and Naxitamab -- 3.4 TRK Inhibitors -- 3.5 Conclusion -- References
內容註 : 4: Design and Statistical Considerations for Early Phase Clinical Trials in Pediatric Oncology -- 4.1 Introduction -- 4.2 Rule-Based Designs -- 4.2.1 Traditional 3 + 3 Design -- 4.2.2 Accelerated Titration Design -- 4.2.3 Rolling Six Design -- 4.3 Model-Based Designs -- 4.3.1 Continual Reassessment Method (CRM) -- 4.3.2 EWOC and BLRM -- 4.3.3 TITE-CRM and TITE-EWOC -- 4.4 Model-Assisted Designs -- 4.4.1 Modified Toxicity Probability Interval (mTPI) Design -- 4.4.2 Keyboard Design -- 4.4.3 Bayesian Optimal Interval (BOIN) Design -- 4.5 New Designs -- 4.5.1 Modified 4 + 4 Design
內容註 : 4.6 Conclusions -- References -- 5: Exploratory Clinical Development: From First in Humans to Phase 3 Ready -- 5.1 Introduction -- 5.2 The Therapeutic Hypothesis -- 5.3 Dose and Schedule Determination -- 5.4 Clinical Proof of Concept (PoC) -- 5.5 Putting It All Together: Combined Phase 1-2 Studies -- 5.6 A Role for Pediatric Cancer in Exploratory Drug Development -- References -- 6: Gene and Cell Therapy: How to Build a BioDrug -- 6.1 Introduction -- 6.2 BioDrug ToolKit: Cells -- 6.2.1 Hematopoietic Stem Cells (HSCs) -- 6.2.2 T Lymphocytes -- 6.2.3 Natural Killer (NK) Cells
標題 : Cancer in children - Treatment. -
標題 : Drug development. -
標題 : Children. -
標題 : Human beings. -
標題 : Pediatrics. -
標題 : Therapeutics. -
標題 : Child -
標題 : Humans -
標題 : Pediatrics -
標題 : Therapeutics -
ISBN : 9783031063572
ISBN : 3031063570
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300 $a1 online resource.
490 1 $aPediatric Oncology
505 0 $aIntro -- Contents -- 1: History of Drug Development for Children with Cancer -- 1.1 Introduction -- 1.2 Initial Progress -- 1.3 Rise of the Cancer Cooperative Groups -- 1.4 Impact of Regulation to Improve Safety and Efficacy Federal Laws Providing a Regulatory Framework for Drug Development in Children -- 1.5 Indications -- 1.6 Summary -- References -- 2: Targeted Small Molecule Drug Discovery -- 2.1 Introduction -- 2.2 Stage Gating -- 2.3 Phenotypic Drug Discovery -- 2.4 Target-Based Drug Discovery: Considerations for Target Selection/Identification
505 8 $a2.5 Target-Based Drug Discovery: Identifying Chemical Starting Points -- 2.6 Hit-to-Lead -- 2.7 Lead Optimization -- 2.8 Candidate Nomination -- References -- 3: An FDA Oncology Perspective of Juvenile Toxicity Studies to Support Pediatric Drug Development -- 3.1 Introduction -- 3.2 Should a JAS Be Considered? -- 3.2.1 ICH S11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines -- 3.2.2 ICH S9: Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers -- 3.3 Dinutuximab and Naxitamab -- 3.4 TRK Inhibitors -- 3.5 Conclusion -- References
505 8 $a4: Design and Statistical Considerations for Early Phase Clinical Trials in Pediatric Oncology -- 4.1 Introduction -- 4.2 Rule-Based Designs -- 4.2.1 Traditional 3 + 3 Design -- 4.2.2 Accelerated Titration Design -- 4.2.3 Rolling Six Design -- 4.3 Model-Based Designs -- 4.3.1 Continual Reassessment Method (CRM) -- 4.3.2 EWOC and BLRM -- 4.3.3 TITE-CRM and TITE-EWOC -- 4.4 Model-Assisted Designs -- 4.4.1 Modified Toxicity Probability Interval (mTPI) Design -- 4.4.2 Keyboard Design -- 4.4.3 Bayesian Optimal Interval (BOIN) Design -- 4.5 New Designs -- 4.5.1 Modified 4 + 4 Design
505 8 $a4.6 Conclusions -- References -- 5: Exploratory Clinical Development: From First in Humans to Phase 3 Ready -- 5.1 Introduction -- 5.2 The Therapeutic Hypothesis -- 5.3 Dose and Schedule Determination -- 5.4 Clinical Proof of Concept (PoC) -- 5.5 Putting It All Together: Combined Phase 1-2 Studies -- 5.6 A Role for Pediatric Cancer in Exploratory Drug Development -- References -- 6: Gene and Cell Therapy: How to Build a BioDrug -- 6.1 Introduction -- 6.2 BioDrug ToolKit: Cells -- 6.2.1 Hematopoietic Stem Cells (HSCs) -- 6.2.2 T Lymphocytes -- 6.2.3 Natural Killer (NK) Cells
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588 0 $aOnline resource; title from PDF title page (SpringerLink, viewed December 2, 2022).
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650 0$aTherapeutics.$331633
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700 1 $aDiMartino, Jorge,$eeditor.$393372
700 1 $aReaman, Gregory H.$eeditor.$393373
700 1 $aSmith, Franklin O.$eeditor.$393374
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776 08$cOriginal$z3031063562$z9783031063565
830 0$aPediatric oncology (Series)$393370
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