Pharmacokinetics in Drug Development.Vol.4

Overview of Oncology Drug Development.- A Global Perspective on First-In-Man Dose Selection: Oncology and Beyond.- Controversies in Oncology: Size-Based vs. Fixed Dosing.- Clinical QTc Assessment in Oncology.- Expediting Drug Development: Breakthrough Therapy Designation.- Pharmacokinetics and Pharmacodynamics of Tyrosine Kinase Inhibitors.- Combination Development.- Role of Pharmacokinetics-Pharmacodynamics in Biosimilar Assessments.- Pharmacokinetics and Pharmacogenetics of Metronomics.- Modeling Tumor Growth in Animals and Humans: an Evolutionary Approach.- Practical Considerations for Clinical Pharmacology in Oncology Drug Development: A Survey of Approvals from 2009-2015.- New Advancements in Exposure-Response Analysis to Inform Regulatory Decision-Making

Peter Bonate has acquired over 22 years of industrial experience: 19 years as a clinical pharmacologist/pharmacokineticist and three years in drug metabolism and bioanalysis. He is currently Executive Director of Pharmacokinetics, Modeling, and Simulation at Astellas. He received his PhD from Indiana University in Medical Neurobiology with an emphasis on the pharmacokinetics of drugs of abuse. He also received an MS in statistics from the University of Idaho and an MS in Pharmacology from Washington State University. He is a Fellow of the American College of Clinical Pharmacology and American Association of Pharmaceutical Scientists (AAPS). Within AAPS he was a founder of the Pharmacometrics focus group, was chair of the Clinical Pharmacology and Translational Research Section, and was AAPS Fellows Committee Chair. Dr. Bonate is a recipient of the AAPS Research Achievement Award in Clinical Pharmacology and Translational Research. He is currently an Associate Editor of the Journal of Pharmacokinetics and Pharmacodynamics. He has served or currently serves on the editorial boards for the Journal of Clinical Pharmacology, Pharmaceutical Research, and the AAPS Journal. He has more than 60 peer-reviewed publications and is author of the books Pharmacokinetic-Pharmacodynamic Modeling and Simulation, 2nd edition and Be a Model Communicator (and sell your models to anyone). Danny R. Howard received his Bachelor of Science degree in Pharmacy, and PhD from the University of Missouri in Kansas City. He joined Novartis as the Head of Global Pharmacokinetics and Pharmacodynamics, and is currently the Vice President of Oncology Clinical Pharmacology for the Novartis Oncology Business Unit. He began working in the pharmaceutical industry first as a biopharmaceutics consultant and then as pharmaceutical scientist for Marion Merrell Dow, Hoechst Marion Roussel, Aventis, and Quintiles. His career has included responsibilities in both clinical and nonclinical pharmacokinetics and

"Part of the series Pharmacokinetics in Drug Development, this book focuses on the unique aspects in the development of oncology drugs. ... the authors present the material at a level accessible to those already involved in PK/PD and drug development. ... Overall, this is a good effort to provide insights into the complexities of oncology drug development for preclinical and clinical pharmacologists and clinicians." (Gregory Reed, Doody's Book Reviews, February, 2017)