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This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry.
List of contents
The discipline of Clinical Pharmacology.- Current issues in drug development.- Current issues in drug regulation.- Current issues in drug reimbursement.- Ethics of clinical research.- GCP, Scientific misconduct.- Phases of drug development, first in man studies.- Clinical trials - Interventional studies.- Clinical trials - observational studies.- Imaging.- Microdosing.- Genomics.- Pharmacokinetics/Pharmacodynamics.- Epidemiology, statistics.- Placebo effects.- Pharmaceutical drug safety.- Drug interactions.- Advanced therapies.- Biological pharmaceuticals.- Generic drugs, Enantiomers.- Special situations I: orphan drugs.- Special situations II: sex differences.- Special situations III: children.
About the author
Prof. Markus Müller, MDRector of the Medical University of ViennaVienna, Austria
Summary
This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry.
Report
"The aim is to describe the role of the discipline of clinical pharmacology in drug discovery. ... The intended audience is faculty, researchers, and advanced students from academia and the pharmaceutical industry who are learning about or involved in the process of drug discovery. ... This book provides a multitude of very useful insights about the successes and failures in drug development for scientists who are, or will be, involved in the process of drug discovery." (Thomas L. Pazdernik, Doody's Book Reviews, May, 2016)
