Safety Pharmacology II-CV, GI, Respiratory and Renal Safety

Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. ICH S7A and ICH S7B guidelines recommend a core battery and supplemental studies to evaluate the effects of new chemical entities on the main organ systems, including central nervous system, cardiovascular, respiratory, gastrointestinal and renal. This article outlines current practices and emerging concepts in safety pharmacology studies of the cardiovascular, respiratory, gastrointestinal and renal systems.