Analytical Method Development

Apr 01, 2010
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain — traditionally produced vaccines take approximately 6 months.
Mar 30, 2010
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
A novel approach for assessing method robustness is described that uses risk-based assessment tools to identify, score, prioritise and then group method parameters.
Mar 01, 2010
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical Technology talked to drugmakers, equipment vendors, and service providers to learn more about the advantages and disadvantages of rapid microbial-detection methods.
Oct 01, 2009
Pharmaceutical Technology Europe PTE
By Pharmaceutical Technology Editors
Dr Martin Cockcroft, Operations Manager at Tepnel Pharmaceutical Services, an established business of Gen-Probe Inc., speaks about harmonized microbiology methods.
Jul 02, 2009
Pharmaceutical Technology
The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.
May 14, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The first project report on FDA's Sentinel website, discusses the evaluation of existing methods for safety signal identification.
Mar 01, 2009
By Pharmaceutical Technology Editors
Development & Validation of an Inductively coupled Mass Spectrometric Method-ABC Labs Whitepaper
Oct 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.

This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).
Apr 27, 2007
Pharmaceutical Technology
Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a conference session, "Performing Analytical Method Validation Robustness for Regulatory Compliance," at Interphex on Thursday.
Nov 30, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Argonne, IL (Nov. 9)-Researchers from Argonne National Laboratory?s Chemistry Division and Xradia have developed a novel X-ray microscopy technique that allows molecular observations of the reactivity of solid surfaces at the nanometer scale, including interfacial reactions such as ion adsorption and catalytic reactions.
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