title: Causality assessment: A brief insight into practices in pharmaceutical industry.
abstract: Healthcare industry is flooded with multitude of drugs, and the list is increasing day by day. Consumption of medications has enormously increased due to life style changes, having safer drugs is the need of the hour. Regulators and other authorities to have a check have put in stringent regulations and pharmacovigilance system in place. Eventhough there has been increase in adverse drug reactions (ADR) reporting in the last decade, causality assessment has been the greater challenge for academicians and even industry. Causality is crucial for risk benefit assessment, particularly when it involves post marketing safety signals. Pharmaceutical companies have put in efforts to have a standardized approach for causality assessment. This article will provide some insight into the approaches for causality assessment from a pharma industry perspective.
authors: Medical Advisor, Immunotherapy division, BIOCON Ltd., Bangalore, Karnataka, India.
authors: R Purushotham
authors: RP
authors: Naidu
keywords: Adverse drug reactions; causality; pharmacovigilance