Pharmacovigilance

Pharmaceutical drugs are a valuable part of patient care throughout the world. For doctors to adequately care for their patients, drug safety must be monitored and reported from initial testing to everyday use. In this article, we explore the world of pharmacovigilance.

Drug development is the process of bringing a novel drug from “bench to bedside”. It can take 10 to 15 years for a drug to be designed, developed and approved for use in patients. Here, we take a closer look at the multi-step process of developing a drug – from start to finish.

In a recent interview with Technology Networks, Dr Stephen Wright, Independent Consultant in medicines development, talks us through the various stages of clinical drug development. He explains what is meant by an IND application, discusses how clinical trials are designed and how the data generated in these trials is processed.

In this article, David Elder discusses the identification of N-nitrosamine impurities in valsartan drug substances products in mid-2018 and highlights the regulatory response, sources of contamination and analytical methods used for identifying nitrosamines.