Tag Archives: FDA


Published 18 Jun 2020

The exciting road ahead for pharmaceutical development

In these confusing, seemingly-endless days of lockdown, it’s important to have milestones to look forward to. We have a few of these coming up at Malvern Panalytical: two within the next couple of weeks!  As you may have already read…READ MORE >

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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

21CFR part 11 for the Zetasizer

Zetasizer: 21CFR? Electronic Record/Electronic Signature? Test Schedule?   What about 21CFR for the Zetasizer? 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…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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Published 1 Jan 2015

Malvern’s Most Wanted: Top Blog Posts of 2014

I’ve been editing Materials Talks for almost a year now, and what a year it’s been! The number of visitors to the blog was 75% higher in 2014 than the previous year;  a testament to the hard work and dedication of…READ MORE >

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Published 3 Jul 2014

Our Take: FDA Guidance on Nanotechnology

Having just attended a nanotech conference in Washington in June, it was interesting to note that the FDA issued a number of guidelines within the same period for companies using nanotechnology in products regulated by the government. Broadly they issued…READ MORE >

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Published 4 Mar 2014

Generic Drug Equivalence

Viva la “sameness” – Ensuring Generic Drug Equivalence Generic drugs make up about 80% of drugs used by US consumers and the percentage of generic drugs used elsewhere around the world is rapidly growing as healthcare costs rise and generic…READ MORE >

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