Pharmacovigilance

Before the safety and efficacy of a new vaccine can be evaluated in a Phase I clinical trial with human subjects, it must first undergo nonclinical safety evaluation in animal models. This article explores the full process.

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 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.

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.