Naidu R Purushotham
Medical Advisor, Immunotherapy division, BIOCON Ltd., Bangalore, Karnataka, India.
Perspect Clin Res. 2013 Oct;4(4):233-6. doi: 10.4103/2229-3485.120173.
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.
医疗保健行业充斥着大量药物，而且这一清单还在日益增加。由于生活方式的改变，药物消费量大幅增长，因此急需更安全的药物。监管机构和其他相关部门为进行管控已制定了严格的法规和药物警戒系统。尽管在过去十年中药物不良反应（ADR）报告有所增加，但因果关系评估对学术界乃至制药行业来说一直都是更大的挑战。因果关系对于风险效益评估至关重要，尤其是当涉及上市后安全信号时。制药公司已努力采用标准化方法进行因果关系评估。本文将从制药行业的角度对因果关系评估方法提供一些见解。
