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http://dx.doi.org/10.1201/9781420018585
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Front MatterAbstract - Hi-Res PDF (688 KB) - PDF w/links (621 KB)
1
Chapter 1. Introduction to Dose Optimization in Drug DevelopmentAbstract - Hi-Res PDF (881 KB) - PDF w/links (490 KB)
15
Chapter 2. Bridging Preclinical and Clinical DevelopmentPaolo ViciniAbstract - Hi-Res PDF (418 KB) - PDF w/links (431 KB)
35
Chapter 3. Bridging Preclinical and Clinical DevelopmentJohn A. WagnerAbstract - Hi-Res PDF (371 KB) - PDF w/links (361 KB)
45
Chapter 4. Dose Selection for First-in-Human (FIH) Trials—Regulatory PerspectiveLois M. FreedAbstract - Hi-Res PDF (433 KB) - PDF w/links (447 KB)
61
Chapter 5. Novel Clinical Trial Designs in Clinical Pharmacology and Experimental MedicineJames BologneseAbstract - Hi-Res PDF (1168 KB) - PDF w/links (667 KB)
85
Chapter 6. Biomarkers, Surrogate Endpoints, and Clinical Endpoints in the Development of Cardiovascular DrugsPeter H. Hinderling, Patrick J. MarroumAbstract - Hi-Res PDF (584 KB) - PDF w/links (421 KB)
97
Chapter 7. PK and PD Variability—Estimation and Appraisal of Its Impact on Dose Optimization with an Example of Gender DifferencesVladimir PiotrovskyAbstract - Hi-Res PDF (1651 KB) - PDF w/links (1530 KB)
159
Chapter 8. Pharmacogenetics (PGx) and Dose ResponseWolfgang M. Schmidt, Markus MullerAbstract - Hi-Res PDF (1153 KB) - PDF w/links (719 KB)
195
Chapter 9. Optimal Dose Finding in Drug DevelopmentJogarao V. S. Gobburu, Mathangi GopalakrishnanAbstract - Hi-Res PDF (774 KB) - PDF w/links (543 KB)
217
Chapter 10. Optimal Dose Selection in Drug DevelopmentWilli Weber, Diether RueppelAbstract - Hi-Res PDF (1770 KB) - PDF w/links (1113 KB)
247
Chapter 11. Dose Optimization Strategy for Strattera, a CYP2D6 SubstrateStephan Chalon, Jennifer W. Witcher, John-Michael SauerAbstract - Hi-Res PDF (493 KB) - PDF w/links (508 KB)
261
Chapter 12. Pediatric Dose Optimization Using Pharmacokinetics and PharmacodynamicsJun ShiAbstract - Hi-Res PDF (1581 KB) - PDF w/links (921 KB)