Pharmacokinetics in Drug Development

1. Overview of Oncology Drug Development
Laeeq Malik, Steven Weitman

2. Overview of Oncology Biomarkers
Mitsukuni Suenaga, Heinz-Josef Lenz, Stefan J. Scherer

3. A Global Perspective on First-in-Man Dose Selection: Oncology and Beyond
Peng Zou, Sau Lee, Min Li, Lawrence Yu, Duxin Sun

4. Controversies in Oncology: Size Based vs. Fixed Dosing
Peter L. Bonate

5. Clinical QTc Assessment in Oncology
Margaret R. Britto, Nenad Sarapa

6. Expediting Drug Development: Breakthrough Therapy Designation
Carmen Ladner

7. Pharmacokinetics and Pharmacodynamics of Tyrosine Kinase Inhibitors
Ana Ruiz-Garcia, Shinji Yamazaki

8. Combination Development
Annie St-Pierre, Maribel Reyes, Vincent Duval

9. Role of Pharmacokinetics: Pharmacodynamics in Biosimilar Assessment
Antonio Silva, Didier Renard

10. Pharmacokinetics and Pharmacogenetics of Metronomics
Nicolas André, Joseph Ciccolini, Marie Amélie Heng, Eddy Pasquier

11. Modeling Tumor Growth in Animals and Humans: An Evolutionary Approach
Dean C. Bottino, Arijit Chakravarty

12. Practical Considerations for Clinical Pharmacology in Drug Development: A Survey of 44 FDA Oncology Approvals
Danny R. Howard

13. New Advancements in Exposure-Response Analysis to Inform Regulatory Decision Making
Liang Zhao, Li Hongshan, Anshu Marathe, Jingyu (Jerry) Yu, Dinko Rekić, Nitin Mehrotra, Vikram Sinha, Yaning Wang

14. Erratum to: Pharmacokinetics and Pharmacodynamics of Tyrosine Kinase Inhibitors
Ana Ruiz-Garcia, Shinji Yamazaki

Keywords: Biomedicine, Pharmaceutical Sciences/Technology, Oncology, Mathematical and Computational Biology