List view / Grid view
19 March 2008 | By
The complexity of drug discovery faces many challenges; principally, the failure of drug candidates during the development process as a result of adverse effects or lack of efficacy. A key reason for this high attrition rate is that we are only just beginning to understand the complexity of the response(s)…
19 March 2008 | By
The impact of biomarker technology and biomarker strategies in pharmaceutical development is still in its infancy; but the impact is already proving significant. Biomarker strategy forms the basis for personalised medicine, the industry/regulatory focus centres on improving the success rate and reducing the high attrition rate often encountered in early…
19 March 2008 | By
High content screening (HCS) is based on subcellular imaging using automated microscopy, in combination with automated image analysis. High content screening was first introduced over a decade ago as one of the promising new technologies, intended to address the bottleneck of secondary assays in the development of new drugs. Since…
19 March 2008 | By
Over the past 40 years, the development of increasingly powerful computers has played a major role in the advancement of laboratory experimentation. Initially, the high processing capabilities of computers were exploited to perform complex calculations at unprecedented speeds, often offline to a company’s main frame.
European Pharmaceutical Review caught up with Mr Neil Kipling, founder and CEO of software giants IDBS, to discuss future prospects and products in advanced solutions software, to serve the ever demanding life sciences industry...
Testing cleaning validation samples requires a validated method. The extent of validation is dependent upon the type of method employed, the capabilities of the method, the scientific and regulatory needs of the resulting data and the anticipated outcome of the testing. A number of test method options are reviewed for…
19 March 2008 | By Danielle Giron, Chemical Research & Development, Novartis Pharma AG, Basel, Switzerland
Thermal analysis techniques cover all methods in which a physical property is monitored as a function of temperature or time, whilst the sample is being heated or cooled under controlled conditions. Calorimetric methods measure the energy involved in every process. The quicker new developments attain the market, such as the…
19 March 2008 | By
The process analytical technology guidelines have been a hotly debated topic within the pharmaceutical industry ever since they were made public in 2004. This also holds true at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), Division of Janssen Pharmaceutical N.V. In recent years, the company has introduced PAT tools…
23 January 2008 | By
The availability of the human and the mouse sequence has allowed genome-wide analysis of transcription to produce 'transcriptomes' that list all RNA transcripts in specific cell types or tissues. These studies have identified a surprisingly large number of ncRNAs that were not recognised by gene annotation programs applied to the…
23 January 2008 | By
Large scale techniques, such as combinatorial chemistry, high throughput screening and the various "omics" techniques, have largely entered the pharmaceutical and diagnosis industry besides the more classical and targeted approaches. Among these large scale techniques, proteomics is one for which there seems to be a widening gap between what is…
23 January 2008 | By
Creating the molecular tools to combat human disease and infection remains the cornerstone activity of the pharmaceutical industry. The methodologies employed to discover new drugs has continually evolved as new biological techniques have emerged1; nevertheless the development of each novel compound is still only realised after many years of careful…
23 January 2008 | By Dr. Neil Campbell, Senior Experimental Officer, Automation and Process Development Specialist, Centre for Materials Discovery, University of Liverpool
With ever mounting market pressure on industries, from increasing global competition, along with consumer desire for value for money and improved performance results there is a greater driving force to stay one step ahead by reducing product time to market. This enforced impetus has many companies having to continually improve…
23 January 2008 | By Stewart Green Director of Quality, Wyeth, UK and Chair, Pharmig
Arguably microbiology is the oldest of the applied sciences, although early exponents doubtless had no understanding of how the fruits of their labour in fermentation for example, came about. The true forerunners of microbiology as it is recognised today would be Koch, Pasteur, Petri et al, who developed much of…
23 January 2008 | By Hans H. Schicht, Dr. sc. Techn, Dr. Hans Schicht Ltd
There are many trends worth reporting in the context of pharmaceutical cleanroom technology: technical as well as regulatory trends. Supporting them is the continuing trend towards worldwide international standards, not only regarding contamination and biocontamination technology, but also regarding related topics such as air filtration. The endeavours for controlling micro-organisms,…
This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position…
