Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance

• By: Staff Editor
• Date: December 05, 2016
• Source: http://www.fda.gov

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance

Pharmacovigilance plays a pivotal role in safeguarding ongoing safety of drug products. It is impossible to recognize all safety concerns during clinical trials. Once a drug is marketed, it is usually exposed to a large number of patients including those with co-morbid conditions.

Post marketing safety drug monitoring includes finding of drug interactions, evaluating the influence of inactive ingredients to the safety profile, methods for comparing safety profiles of similar drugs, investigation of the adverse effects on human health of drug residues in animals, e.g. antibiotics and hormones.

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