Abstract

PHARMACOVIGILANCE AND DRUG SAFETY IN CLINICAL TRIALS

Dnyaneshwari Sakhare*, Neha Zod, Harigopal Sawarkar, Umesh Bansod and Nikita Mahalle

Abstract

Patient safety has always been a primary focus in the development of new pharmaceutical products. Pharmacovigilance is that the science and activities associated with the gathering, detection and assessment of adverse event data. Major purpose of pharmacovigilance is to gauge the benefit- risk profile of drug for better efficacy and safety to be used in patients. Pharmacovigilance plays a major role in rationale use of drug which provides the information about the adverse drug reactions which seen inpatients. Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Drug safety and pharmacovigilance are rapidly changing with biomarkers and new technologies such as artificial intelligence. However, we need new ideas and application contexts for integration of biomarkers and emerging technologies in modern pharmacovigilance.

Keywords: Pharmacovigilance, clinical trials, adverse drug reactions, drug safety, centers for Panvigilance.