Serum biomarkers in nonalcoholic steatohepatitis: value for assessing drug effects?

Nonalcoholic steatohepatitis (NASH) is a common chronic liver disease throughout the world. In the USA, approximately 3-5% of the population are affected, and the prevalence of this condition is increasing. NASH is associated with an increased risk of liver-related morbidity, such as cirrhosis and fibrosis, as well as cardiovascular disease, and in spite of several clinical studies investigating putative new drugs, no approved treatment is currently available.

Clinical pharmacology, biomarkers and personalized medicine: education please.

Over the past decades, the scope of clinical pharmacology within the pharmaceutical industry has widened considerably. Key growth has been in the area of translational science and exploratory medicine, where clinical pharmacologists are nowadays the mediator between basic research and establishment of clinical usefulness. This role has led to and is supported by the rapid developments in pharmacokinetic-pharmacodynamic modeling and simulation, a strong focus on biomarkers for early informed decision-making, and the advent of pharmacogenomics into safety and efficacy predictions and evaluations.