Pharmacokinetics in Drug Development (PDF)
Back cover copy
In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development...
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Back cover copy
In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely - to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamicconcepts for tyrosine kinases,the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist's point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.
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
- 2016, 1st ed. 2016, 330 Seiten, Englisch
- Herausgegeben: Peter L. Bonate, Danny R. Howard
- Verlag: Springer-Verlag GmbH
- ISBN-10: 3319390538
- ISBN-13: 9783319390536
- Erscheinungsdatum: 06.10.2016
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- Größe: 8.13 MB
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