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THE PHARMA REVIEW (MARCH APRIL 2015)

Patient Safety through Clinical Trials and Pharmacovigilance

Anantha Naik Nagappa, Lalith Kumar Mittal, Titiksha Darekar & Uday Venkat Mateti

Introduction: The drugs evolution into an important component has a history of nearly 300 years. The World War I and II and aftermath have a tremendous influence on drug discovery, development and marketing. Drugs became an important commercial commodity when several manufacturers started competing for the market share. The discovery of sulphonamide, insulin and the aspirin stand a landmark in drug discovery. The drug development became systemized following episodes of thalidomide tragedy, diethylstilbestrol tragedy which led to the systematic approach of drug development1. The drug development currently starts from in-vitro experimentation to establish the proof of concept of drug action followed by animal experimentation known as Pre Clinical Studies with an objective of establishing the guidelines of mechanism of action, therapeutic utility. Following the preclinical studies the drug development process begins in human experimentation and is divided into 4 phases2. 

 

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