Published 18 Jun 2020
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 >
Tags: drugs, FDA, nasal sprays
Published 20 Dec 2018
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 >
Tags: FDA, ISO 17025, poster, Royal Society of Chemistry
Published 31 Aug 2017
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 >
Tags: ANDA, API, bioequivalence, FDA, MDRS
Published 22 Aug 2017
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 >
Tags: 21 CFR, 21CFR, 21CFR11, 21CFRpart11, FDA
Published 14 Jun 2016
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 >
Tags: ANDA, CDER, FDA, mometasone furoate
Published 24 Feb 2015
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 >
Tags: buoyant mass, dynamic light scattering, FDA, morphologi G3-ID, Nanoparticle Tracking Analysis
Published 1 Jan 2015
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 >
Tags: DLS, dynamic light scattering, FDA, nanoparticle, nanotechnology
Published 3 Jul 2014
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 >
Tags: DLS, FDA, nano regulations, Nanomaterials, nanoparticles
Published 4 Mar 2014
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 >
Tags: bio-equivalence, FDA, generic drugs, morphologi G3-ID, morphological imaging