Tag Archives: FDA


Published 20 Dec 2018

Regulatory Hot Topics III

Joint Pharmaceutical Analysis Group; Royal Society of Chemistry, London Malvern Panalytical had pleasure in presenting a poster on USP<232> and ICH Q3D Elemental Impurities Standards for X-Ray Fluorescence Analysis at the Regulatory Hot Topics III, Joint Pharmaceutical Analysis Group at…READ MORE >

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Published 31 Aug 2017

Morphologically-Directed Raman Spectroscopy (MDRS)

GEN covers the role of MDRS in reducing the need for clinical bioequivalence endpoint studies     Raman spectroscopy and MDRS enable determination of the size and shape of specific components within a multi-component blend. This article followed the recent…READ MORE >

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Published 22 Aug 2017

21 CFR part 11 for the Zetasizer

Zetasizer: 21CFR? Electronic Record/Electronic Signature? Test Schedule?   The Malvern Zetasizer is an extremely versatile measurement system. By far the most systems are used in academic and industry research laboratories, for example in fundamental research, drug discovery, or formulation optimization….READ MORE >

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Published 14 Jun 2016

FDA highlights Malvern’s innovative MDRS technology for Complex Generic drug product development

MDRS Technology Finally!  After what has felt like one of the wettest and longest winters in memory here in the UK, we’re now heading into the long, mellow days of midsummer. But casting its miserable shadow over the barbecues, school…READ MORE >

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Published 24 Feb 2015

Understanding protein aggregation – the key to product quality & patient safety

I recently took part in a question and answer session with BioPharm International about techniques for measuring and characterizing protein aggregates. The full discussion can be viewed here, however I thought I would also use this blog post to summarize…READ MORE >

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