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Pharmacokinetics in Drug Development - Problems and Challenges in Oncology, Volume 4 (Hardcover, 1st ed. 2016)
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Pharmacokinetics in Drug Development - Problems and Challenges in Oncology, Volume 4 (Hardcover, 1st ed. 2016)
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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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