SAFETY PHARMACOLOGY

Anjula Sachan, Sarvesh Singh, Pratap Shankar*, Dheeraj Kumar Singh, Rajendra Nath, Amod Kumar Sachan and Rakesh Kumar Dixit

ABSTRACT

Safety pharmacology is the study of the potential undesirable pharmacodynamic effects of a substance in relation to dosage within the substance's therapeutic range and above. It is a rapidly developing discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment. The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic relationship of a drug’s adverse effects using continuously evolving methodology. It includes within its hold over a regulatory requirement to predict the risk of rare lethal events. The key issues for Safety Pharmacology are detection of an adverse effect liability, projection of the data into safety margin calculation and finally clinical safety monitoring. Integration of the newer approaches to routine Safety Pharmacology studies may significantly enhance the scope of Safety Pharmacology by refining and providing mechanistic insight to potential adverse effects associated with test compounds. The purpose of this review is to provide a combined and comprehensive overview of both current practices and newer technologies, followed by the emerging concepts in Safety pharmacology studies: risk determination assessments, Use of drugs with dependence liability integration of Safety pharmacology endpoints into regulatory toxicology studies, drug–drug interactions and future directions in Safety pharmacology.

Keywords: Pharmacodynamic effects, pharmacodynamic/pharmacokinetic.