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Pharmacokinetics in Drug Development: Clinical Study Design and Analysis (Volume 1) de Peter L. Bonate

Pharmacokinetics in Drug Development: Clinical Study Design and Analysis (Volume 1)

Editat de Peter L. Bonate, Danny R. Howard
en Limba Engleză Hardback – 5 dec 2005
These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. Geared toward graduate level students and scientists in the areas of clinical pharmacology and PK, the volumes will fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs, including first-time-in-man, biopharmaceuticals, and special population studies. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.
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Specificații

ISBN-13: 9780971176744
ISBN-10: 0971176744
Pagini: 628
Ilustrații: XII, 628 p.
Dimensiuni: 178 x 254 x 35 mm
Greutate: 1.32 kg
Ediția:2004
Editura: American Assoc. of Pharm. Scientists
Colecția American Association of Pharmaceutical Scientists
Locul publicării:Arlington, VA, United States

Public țintă

Research

Cuprins

First-Time-in-Man Studies.- Drug-Drug Interactions.- Food Effect Studies.- Bioavailability and Bioequivalence Studies.- Mass Balance Studies.- Design, Conduct, and Analysis of Studies in Patients with Hepatic Impairment.- Design, Conduct, and Analysis of Studies in Patients with Renal Impairment.- Special Populations.- Non-compartmental Analysis.- Analysis of Urine Excretion Data.- Compartmental Models.- The Role of Metabolite Pharmacokinetics and Pharmacodynamics in Drug Development.- Average, Population, and Individual Bioequivalence.- Assessment of Dose Proportionality.- Analysis of Absorption Kinetic Data.- Interspecies Pharmacokinetic Scaling: Principles, Applications, and Limitations.- In Vitro Drug Metabolism Information in the Prediction of Human Pharmacokinetics.- Practical Deconvolution.- Population Pharmacokinetics: Applications in Industry.- Clinical Trial Simulation.- The Strategic Role and Application of Pharmacokinetic/Pharmacodynamic Modeling in Drug Development.- The Analysis of Clincal Safety Data in Phase I-II Pharmacokinetic Studies.

Caracteristici

Brings together academic science and the practical application of knowledge in drug development

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)

Notă biografică

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 pharmacodynamics, bioanalytics, pharmaceutical business operations and drug metabolism and pharmacokinetics. He has worked with numerous worldwide new drug submissions supporting both large and small molecules, within and outside the area of oncology. He was a charter member of the Missouri Biotech Association and served as its first Board Chairman. He is a member of American Association of Pharmaceutical Scientists (AAPS), American Society for Clinical Pharmacology and Therapeutics (ASCPT) and American Society of Clinical Oncology (ASCO). He is an accomplished author or coauthor of over 50 scientific publications and presentations in the area of clinical pharmacology and pharmaceutical sciences.

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.