Clinical Pharmacology: Current Topics and Case Studies

Prof. Markus Müller, MDRector of the Medical University of ViennaVienna, Austria

• 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.

“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)