Hugendubel.info - Die B2B Online-Buchhandlung 

Merkliste
Die Merkliste ist leer.
Bitte warten - die Druckansicht der Seite wird vorbereitet.
Der Druckdialog öffnet sich, sobald die Seite vollständig geladen wurde.
Sollte die Druckvorschau unvollständig sein, bitte schliessen und "Erneut drucken" wählen.

Pharmacokinetics in Drug Development

Advances and Applications, Volume 3 - Previously published in hardcover
BuchKartoniert, Paperback
319 Seiten
Englisch
Springererschienen am23.08.2016Softcover reprint of the original 1st ed. 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.mehr
Verfügbare Formate
BuchKartoniert, Paperback
EUR213,99
BuchGebunden
EUR213,99

Produkt

KlappentextThe 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.
ZusammenfassungPharmacokinetics in Drug Development focuses on the current development of technological issues facing drug development teams. Topics include the characterization of drug disposition in pregnant subjects, the measurement of arrhythmic potential, tumor growth modeling, and more.
Details
ISBN/GTIN978-1-4899-7799-1
ProduktartBuch
EinbandartKartoniert, Paperback
Verlag
Erscheinungsjahr2016
Erscheinungsdatum23.08.2016
AuflageSoftcover reprint of the original 1st ed. 2011
Seiten319 Seiten
SpracheEnglisch
Gewicht640 g
IllustrationenXII, 319 p.
Artikel-Nr.43959821

Inhalt/Kritik

Inhaltsverzeichnis
Preface1. Modeling Tumor Growth in OncologyPeter L. Bonate2. Drug-Drug Interactions: Designing Development Programs and Appropriate Product LabelingJ. Matthew Hutzler, Jack Cook, and Joseph C. Fleishaker3. Modeling the Progression of DiseaseDiane R. Mould4. The Use of Dried Blood Spots for Concentration Assessment in Pharmacokinetic EvaluationsTapan K. Majumdar and Danny R. Howard5. Microdosing: Pharmacokinetic and Metabolism Data Early in the Drug Development ProcessGraham Lappin6. Metabolite Testing in Drug DevelopmentAngus N. R. Nedderman and Don K. Walker7. The -Omics in Drug DevelopmentMajid Y. Moridani, Robyn P. Araujo, Caroline H. Johnson, and John C. Lindon8. Optimal Design of Pharmacokinetic-Pharmacodynamic StudiesLee-Kien Foo and Stephen B. Duffull9. Pharmacokinetic Studies in Pregnant WomenJamie L. Renbarger and David M. Haas10. Design, Conduct and Analysis of Thorough QT StudiesTanya Russell, Daniel S. Stein, and David J. Kazierad11. Contribution of Quantitative Whole-body Autoradioluminography to the Early Selection and Development of Drug CandidatesAlain Schweitzer12. Pharmacokinetics, Modeling, and Simulation in the Development of Sunitinib Malate: A Case StudyBrett E. Houk and Carlo L. Bello13. The Clinical Significance of Drug Transporters in Drug Disposition and Drug InteractionsThomas N. Thompsonmehr

Autor


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 consultantand 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.