药物警戒杂志

抽象的

Pharmacovigilance Safety Monitoring in Clinical Trails

Yashwant D. Nakhate, Mohammed Tauqeer Sheikh, Kanchan S. Talekar, Sapana Tadas

Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies. As the industry transitions from passive to active safety surveillance activities, there will be greater demand for more comprehensive and innovative approaches that apply quantitative methods to accumulating data from all sources, ranging from the discovery and preclinical through clinical and post-approval stages. Statistical methods, especially those based on the Bayesian framework, are important tools to help provide objectivity and rigor to the safety monitoring process. Pharmacovigilance (PV) is a scientific activity which keeps constant watch on the drug throughout its life cycle. In India, Indian Pharmacopoeia Commission (IPC) and National Coordination Committee (NCC) through the Central Drug Standard Control Organization (CDSCO) cordially regulate the PV activity. To build a potential PV system in India, Pharmacovigilance Program of India (PvPI) have been proposed and implemented by the Indian government in 2010. The accurate detection and reporting of ADR is a heart of this system.