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Pharmacokinetics in Drug Development: Advances and Applications, Volume 3 de Peter L. Bonate

Pharmacokinetics in Drug Development: Advances and Applications, Volume 3

Editat de Peter L. Bonate, Danny R. Howard
en Limba Engleză Hardback – 22 feb 2011
The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams.  They regard the practical considerations for assessment of selected special development populations.  For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling.  Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection.  Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry. 
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Specificații

ISBN-13: 9781441979360
ISBN-10: 1441979360
Pagini: 332
Ilustrații: XII, 319 p.
Dimensiuni: 178 x 254 x 24 mm
Greutate: 0.77 kg
Ediția:2011
Editura: Springer Us
Colecția Springer
Locul publicării:New York, NY, United States

Public țintă

Research

Cuprins

Preface
1.    Modeling Tumor Growth in Oncology
Peter L. Bonate
2.    Drug-Drug Interactions: Designing Development Programs and Appropriate Product Labeling
J. Matthew Hutzler, Jack Cook, and Joseph C. Fleishaker
3.    Modeling the Progression of Disease
Diane R. Mould
4.    The Use of Dried Blood Spots for Concentration Assessment in Pharmacokinetic Evaluations
Tapan K. Majumdar and Danny R. Howard
5.    Microdosing: Pharmacokinetic and Metabolism Data Early in the Drug Development Process
Graham Lappin
6.    Metabolite Testing in Drug Development
Angus N. R. Nedderman and Don K. Walker
7.    The –Omics in Drug Development
Majid Y. Moridani, Robyn P. Araujo, Caroline H. Johnson, and John C. Lindon
8.    Optimal Design of Pharmacokinetic-Pharmacodynamic Studies
Lee-Kien Foo and Stephen B. Duffull
9.    Pharmacokinetic Studies in Pregnant Women
Jamie L. Renbarger and David M. Haas
10.  Design, Conduct and Analysis of Thorough QT Studies
Tanya Russell, Daniel S. Stein, and David J. Kazierad
11.  Contribution of Quantitative Whole-body Autoradioluminography to the Early Selection and Development of Drug Candidates
Alain Schweitzer
12.  Pharmacokinetics, Modeling, and Simulation in the Development of Sunitinib Malate: A Case Study
Brett E. Houk and Carlo L. Bello
13.  The Clinical Significance of Drug Transporters in Drug Disposition and Drug Interactions
Thomas N. Thompson

Notă biografică

Peter Bonate has 16 years industrial experience, 13 years as a clinical pharmacologist/pharmacokineticist and 3 years in drug metabolism and bioanalysis.  He is currently a Director in the Clinical Pharmacology, Modeling, and Simulation department at GlaxoSmithKline in the oncology therapeutic area.   He has also worked at Genzyme, Hoechst Marion Roussel, Eli Lilly, and Quintiles.  He received his Ph.D. in 1996 from Indiana University in Medical Neurobiology with an emphasis on the pharmacokinetics of drugs of abuse.  He received an MS in statistics from the University of Idaho and an MS in Pharmacology from Washington State University both in 1990.  In 2003 he was elected a Fellow of the American College of Clinical Pharmacology and in 2007 was elected a fellow of the American Association of Pharmaceutical Scientists (AAPS).  He was founder of the Modeling and Simulation focus group, has served as chair of the population pharmacokinetics focus group, and was section leader for the Clinical Pharmacology and Translational Research Section within AAPS.  He has served or currently serves on the editorial boards for the Journal of Clinical Pharmacology, Pharmaceutical Research, Journal of Pharmacokinetics and Pharmacodynamics, and the AAPS Journal.  He has more than 40 publications in the field of pharmacokinetics and clinical pharmacology, is co-editor of the 2-volume series Pharmacokinetics in Drug Development published by AAPS Press in 2004, and is author of the book Pharmacokinetic-Pharmacodynamic Modeling and Simulation  published by Springer in 2005.
 
Danny Howard received his Bachelor's of Science degree in Pharmacy, and Ph.D. from the University of Missouri in Kansas City.  He began working in the pharmaceutical industry in 1991, first as a biopharmaceutics consultant and then as pharmaceutical scientist for Marion Merrell Dow, Hoechst Marion Roussel, Aventis, and Quintiles.  He is currently the Vice President of Global Pharmacokinetics and Pharmacodynamics for Novartis.  His career has included responsibilities in both clinical and nonclinical pharmacokinetics and pharmacodynamics, bioanalytics, and pharmaceutical business operations. He has worked with numerous drug submissions supporting both large and small molecules worldwide.  He was a charter member of the Missouri Biotech Association and served as its first Board Chairman.  With Peter Bonate, he was the co-editor of the series Pharmacokinetics in Drug Development published by AAPS Press in 2004.

Caracteristici

Provides practical guidance on the application of pharmacokinetics as a drug development science
Includes characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling
Introduces important technologies
Includes supplementary material: sn.pub/extras

Recenzii

“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)

Textul de pe ultima copertă

 
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.