An overview of some pharmacological methods used in safety pharmacology studies.
Safety Pharmacology is an integrated discipline that has evolved from the distinct fields of pharmacology, physiology and toxicology. Studies conducted under the guidance of 'Safety Pharmacology' are used to further the discovery, but more importantly, characterize the development of 'safe' biologically active new chemical entities (NCE). Safety Pharmacology studies identify, monitor and characterize potentially undesirable pharmacodynamic activities in non- or pre-clinical studies. This cursory review will highlight the history of Safety Pharmacology and overview the general recommendations of testing strategies used for preclinical core battery studies that are required according to the ICH regulatory S7A and S7B guidelines.
Pugsley
Michael K
MK
Pharmacology, Forest Research Institute, Harborview Financial Center, Jersey City, NJ 07311, USA. Michael.Pugsley@frx.com
D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D010600:Pharmacology / Q000379:methods* / Q000639:trends*; D012107:Research Design; D012449:Safety