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Bio-mimetic chromatography to predict drug distribution in vivo

29 October 2010 | By Klara Valko, Analytical Chemistry, GlaxoSmithKline Medicines Research Centre

A major concern for the pharmaceutical industry is the high attrition rate (>90 per cent) of potential drug molecules failing during late stages of the drug discovery process. This may be due to lack of efficacy in the clinic, unexpected side effects or unfavourable pharmacokinetics. There is a need for…

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ICH Q10 knowledge management

3 September 2019 | By

The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to…

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Pharmaceutical QbD: Omnipresence in the product development lifecycle

18 April 2017 | By , ,

The concept of Quality by Design (QbD) was implemented by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and United States Food and Drug Administration (FDA) around a decade ago, with the aim of adopting systematic approaches for developing high-quality pharmaceutical products for patients’…

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The importance of disaccharide excipients in biologics

17 February 2021 | By , ,

Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…

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Evaluation of cellular response to nicotinic compounds using optical label-free technology

16 February 2011 | By Isabel Coma & Julio J. Martin, Screening and Compound Profiling, GlaxoSmithKline R&D Pharmaceuticals

Cell signalling circuits are likely to have a key role in the future of pharmacological discovery and medical treatment. There is consensus about the importance of understanding cell components and their function, not at the level of genes, but at a higher level of abstraction, involving their pathways and circuits.…

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Fast-scan differential scanning calorimetry

2 August 2008 | By

Differential scanning calorimetry (DSC) is a widely used technique within the pharmaceutical industry because the range of phase transitions it can measure usually allows near complete physical characterisation of a new active principal early during preformulation. In addition, because DSC measures a property change that is ubiquitous† (heat) there are…

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Towards a comprehensive open source platform for management and analysis of High Content Screening data

19 August 2010 | By Karol Kozak, Angela Bauch, Gabor Csucs,Tomasz Pylak & Bernd Rinn, ETH Zurich

As High Content Screening (HCS) has moved into the mainstream for biological and pharmaceutical investigations, a lag of well integrated pipelines for automated acquisition, management and analysis of HCS results turns out to be a bottleneck for fully leveraging the wealth of information contained in a screen and moving to…