Dose Finding in Drug Development

1. Introduction and New Drug Development Process
Naitee Ting

2. Dose Finding Based on Preclinical Studies
David Salsburg

3. Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose
Marlene Modi

4. Dose-Finding in Oncology—Nonparametric Methods
Anastasia Ivanova

5. Dose Finding in Oncology—Parametric Methods
Mourad Tighiouart, André Rogatko

6. Dose Response: Pharmacokinetic–Pharmacodynamic Approach
Nick Holford

7. General Considerations in Dose–Response Study Designs
Naitee Ting

8. Clinical Trial Simulation—A Case Study Incorporating Efficacy and Tolerability Dose Response
Wayne Ewy, Peter Lockwood, Candace Bramson

9. Analysis of Dose–Response Studies—Emax Model
James Macdougall

10. Analysis of Dose–Response Studies—Modeling Approaches
José C. Pinheiro, Frank Bretz, Michael Branson

11. Multiple Comparison Procedures in Dose Response Studies
Ajit C. Tamhane, Brent R. Logan

12. Partitioning Tests in Dose–Response Studies with Binary Outcomes
Xiang Ling, Jason Hsu, Naitee Ting

13. Analysis of Dose–Response Relationship Based on Categorical Outcomes
Christy Chuang-Stein, Zhengqing Li

14. Power and Sample Size for Dose Response Studies
Mark Chang, Shein-Chung Chow

DRM-restrictions

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Keywords: TECHNOLOGY & ENGINEERING / Biomedical TEC059000