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Clinical Trial Simulations: Applications and Trends by Holly H.C. Kimko (English

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Specificaties

Objectstaat
Nieuw: Een nieuw, ongelezen en ongebruikt boek in perfecte staat waarin geen bladzijden ontbreken of ...
ISBN-13
9781461427841
Book Title
Clinical Trial Simulations
ISBN
9781461427841
Publication Year
2013
Series
Aaps Advances in the Pharmaceutical Sciences Ser.
Type
Textbook
Format
Trade Paperback
Language
English
Publication Name
Clinical Trial Simulations : Applications and Trends
Author
Carl C. Peck
Item Length
9.3in
Publisher
Springer New York
Item Width
6.1in
Item Weight
29.7 Oz
Number of Pages
Xvi, 540 Pages

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Product Information

This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS.The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.

Product Identifiers

Publisher
Springer New York
ISBN-10
1461427843
ISBN-13
9781461427841
eBay Product ID (ePID)
160097838

Product Key Features

Author
Carl C. Peck
Publication Name
Clinical Trial Simulations : Applications and Trends
Format
Trade Paperback
Language
English
Publication Year
2013
Series
Aaps Advances in the Pharmaceutical Sciences Ser.
Type
Textbook
Number of Pages
Xvi, 540 Pages

Dimensions

Item Length
9.3in
Item Width
6.1in
Item Weight
29.7 Oz

Additional Product Features

Series Volume Number
1
Number of Volumes
1 Vol.
Lc Classification Number
R850.A1-854
Reviews
From the reviews:'Clinical Trial Simulations: Applications and Trends' covers the evolving use of mathematical simulation models to supplement and sometimes even replace clinical trials. The book is primarily intended for clinical trialists and drug development and regulatory scientists. (Norman M. Goldfarb, Journal of Clinical Research Best Practice, Vol. 8 (7), July, 2012), From the reviews: "'Clinical Trial Simulations: Applications and Trends' covers the evolving use of mathematical simulation models to supplement and sometimes even replace clinical trials. The book is primarily intended for clinical trialists and drug development and regulatory scientists." (Norman M. Goldfarb, Journal of Clinical Research Best Practice, Vol. 8 (7), July, 2012)
Table of Content
Clinical Trial Simulation and Quantitative Pharmacology.- Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective.- Contribution of Modeling and Simulation in the Regulatory Review and Decision-Making: U.S FDA Perspective.- Decision-Making in Drug Development: Application of a Model Based Framework for Assessing Trial Performance.- Decision-Making in Drug Development: Application of a Clinical Utility Index.- Adaptive Trial Designs.- Keys of Collaboration to Enhance Efficiency and Impact of Modeling and Simulation.- Leveraging Pharmacometrics in Early Phase Anti-Inflamatory Dug Development.- The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents.- Modeling and Simulation in the Development of Cardiovascular Agents.- Viral Dynamic Modeling and Simulations in HIV and Hepatitis C.- A Model-Based PK/PD Antimicrobial Chemotherapy Drug Development Platform to Simultaneously Combat Infectious Diseases and DrugResistance.- PKPD and Disease Modeling: Concepts and Applications to Oncology.- Application of Pharmacokinetic-Pharmacodynamic Modeling and Simulation for Erythropoietic Stimulating Agents.- Model Based Development of an Agent for the Treatment of Generalized Anxiety Disorder.- Balancing Efficacy and Safety in the Clinical Development of an Atypical Antipsychotic, Paliperidone Extended-Release.- Application of Modeling and Simulation in the Development of Protein Drugs.- Modeling and Simulation in Pediatric Research and Development.- Disease Progression Analysis: Towards Mechanism-Based Models.- Using a Systems Biology Approach to Explore Hypotheses Underlying Clinical Diversity of the Renin Angiotensin System and the Response to Antihypertensive Therapies.- Recent Developments in Physiologically Based Pharmacokinetic Modeling.- Covariate Distribution Models in Simulation
Copyright Date
2011
Topic
Clinical Medicine, Life Sciences / Biochemistry, Pharmacology, Research
Intended Audience
Scholarly & Professional
Illustrated
Yes
Genre
Science, Medical

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