List view / Grid view
Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias1. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on…
29 February 2016 | By Warren Hochfeld, Jenna Riffell and Neil Levinson from Kaiser Associates
With 2015 giving some hints of what is to come, the Kaiser Associates European Healthcare team are predicting another year of big disruptions, transformations and innovations as the healthcare industry continues to overhaul outmoded business models...
29 February 2016 | By Jasminder Sahi and Yi Li, Sanofi R&D
The human brain is the most highly perfused organ in the body, being composed of over 100 billion capillaries with an average inter-capillary distance of 50μm and a length greater than 600km. This extensive network of blood vessels facilitates the delivery of nutrients and oxygen to the brain, while providing…
29 February 2016 | By Phil Borman, Simon Bate and Keith Freebairn, GlaxoSmithKline
Skip testing is a process employed to reduce the analytical drugs testing burden and lends itself to processes with high frequency batch production. Rather than test all batches within a given interval, pre-selected batches are assessed and the other batches ‘skipped’. This reduction is justified as it is shown that…
Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…
29 February 2016 | By SOTAX Group
There are several sources of variability in the “inherently poor design” of compendial dissolution apparatus types. Nevertheless, dissolution testing is a QC requirement for many products, and so the industry faces the challenge of implementing and managing fleets of dissolution equipment. However, through instrument and process design and automation, managing…
Completing risk assessments is an inherent part of good manufacturing practice (GMP) and risk-based environmental control and monitoring (EM) in sterile product filling within isolators and restricted access barrier systems (RABS). This article considers the challenges the pharmaceutical industry faces in characterising conventional risk assessments like failure modes and effects…
In this article, Kerstin Barr, Product Manager for handheld Raman instruments at Thermo Fisher Scientific, comments on the revised tolerances...
26 February 2016 | By Rodrigo Barnes, Chief Technology Officer at Aridhia
Here, Rodrigo Barnes, Chief Technology Officer at Aridhia, discusses how data analytics can add value to proof of concept trials...
26 February 2016 | By Sini Eskola, Director, European Federation of Pharmaceutical Industries and Associations (EFPIA)
This review looks at the steps needed to complete clinical trials in the European Union (EU) and describes the rigorous regulatory framework involved in clinical research...
Natural killer receptor T-cells have the potential to become a real game changing treatment for patients with cancer. Here, Dr Frédéric Lehmann, VP Immuno-Oncology, Celyad, discusses this new cancer fighting technology...
15 February 2016 | By Robert Yardy, Head of New Business and Marketing, MMT Digital
Robert Yardy of MMT Digital, a company that redeveloped Allergan's corporate website, discusses the value to pharmaceutical companies of having a responsive, fully functional website...
10 February 2016 | By Victoria White, European Pharmaceutical Review
The MRC has launched a £1m rapid response funding initiative to better understand the nature of the risk posed by the Zika virus. Find out about this initiative and NIH's call for research here...
4 February 2016 | By Victoria White, European Pharmaceutical Review
The Zika virus has taken hold in South America. Its possible link to microcephaly in newborn babies and neurological conditions has led the World Health Organization to declare a Public Health Emergency of International Concern. Here we discuss the virus, countermeasures and the race for a vaccine.
29 January 2016 | By Adewale Joseph Ogunleye, Adekunle Ajasin University, Akungba Akoko, Ondo State, Nigeria
This article explores how scientists are developing a fast, qualitative and specific technique for the detection and classification of microorganisms...
