EAN: 9783319390512

PHARMACOKINETICS IN DRUG DEVELOPMENT GEBUNDEN

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-pharmacodynamic concepts
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.

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