Open AccessCausality assessment: A brief insight into practices in pharmaceutical industry
Author(s) -
R Purushotham Naidu
Publication year - 2013
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/2229-3485.120173
Subject(s) - causality (physics) , pharmacovigilance , pharmaceutical industry , safer , perspective (graphical) , business , drug reaction , risk analysis (engineering) , medicine , marketing , drug , pharmacology , computer science , computer security , physics , quantum mechanics , artificial intelligence
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.