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GlaxoSmithKline (GSK)

 

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Can HPLC assay methods really be considered quality critical tests?

5 September 2014 | By

Analytical method specificity is assessed using ICH (International Conference on Harmonisation) Q2 (2005). Although, certain methods are not specific enough for their intended purposes, they may have other advantages. Both titrimetric and UV (Ultra-violet spectroscopy) assays are non-specific, but have superior precision (ca. 0.1-0.5% RSD (Residual Standard Deviation)) compared with…

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GSK receives FDA approval of an additional Promacta® (eltrombopag) indication for use in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST)

27 August 2014 | By GlaxoSmithKline

GlaxoSmithKline plc announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for the once-daily use of Promacta® (eltrombopag) in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy...

article

What does quality mean to you?

3 July 2014 | By

An effective quality risk management (QRM) process ensures proactive identification and control of potential issues that may arise during development and commercialisation. Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the…