Global harmonization of drug safety testing began in the 1990s with the formation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH has published a number of documents (guidelines) that are universally used to test the safety of new drug candidates around the world.
Guidance for cardiovascular testing in Safety Pharmacology is covered in 2 documents: S7A and S7B. S7A addresses safety testing including the guidelines that all drug candidates should determine effects on blood pressure, heart rate, and the electrocardiogram. In vivo, in vitro and/or ex vivo evaluations, including methods for repolarization and conductance abnormalities, should also be considered.
Additionally, if warranted, further evaluation of the following endpoints may need to be studied including cardiac output, ventricular contractility, vascular resistance, the effects of endogenous and/or exogenous substances on the cardiovascular responses.
Recently many organizations have begun to combine Safety Pharmacology studies with traditional Toxicology studies in an effort to increase the number of valuable endpoints and reduce costs; this is achieved by spending more on the Toxicology Studies, while reducing or eliminating the Safety Pharmacology studies in the drug development process.
DSI has a long history of providing the essential tools to measure cardiovascular endpoints in both Safety Pharmacology and Toxicology studies. DSI also provides GLP-compliant systems for acquisition and reporting.