Biopharmaceutics and Biologic Drugs

Pharmacovigilance

Pharmacovigilance is to provide a complete information reagarding drug safety and various benefits associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events which could not be provided by clinical trials involving in-vivo method. Pharmacovigilance legislation gives an outlook on the rules and regulations to follow in Pharmacovigilance practice. A Pharma industry in the improvement of pharmacovigilance system is very crucial to maintain the safety data, Detection and Evaluation of drug safety signals through manual and medical devices reporting. Pharmacovigilance scope also deals as Ecopharmacovigilance (EPV), pharmaco environmentology and pharmacovigilance in herbal medicines. Drug Safety is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse side effects with pharmacological action of pharmaceutical products. According to US FDA a drug is regarded as safe by looking at side effects, its manufacturing process and results of animal testing and clinical trials.