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.

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. .