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.
Зміст
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.
Про автора
Prof. Markus Müller, MD
Rector of the Medical University of Vienna
Vienna, Austria
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