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PAT supplement 2011

15 December 2011 | By

In this PAT supplement: The historical development of the FDA's PAT initiative and its present course; Implementation of modelling approaches in the QbD framework: Examples from the Novartis experience; Challenges in development and implementation of spectroscopic techniques as PAT Analysers...

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Under the Microscope: Philip Irving, FOSS NIRSystems Inc.

13 December 2011 | By Philip Irving, President, FOSS NIRSystems, Inc.

FOSS NIRSystems, Inc. has a long, complicated and rich history tracing back to 1966 when NEOTEC Corporation was founded. Through a number of acquisitions and mergers, NIRSystems was trademarked in 1989 and bought by Perstorp Analytical, before the company was bought by FOSS in 1997, strengthening the company’s pharmaceutical division.…

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Abbott receives CE Mark for new hepatitis test

9 November 2011 | By

Abbott announced it has received CE Marking (Conformité Européenne) in the European Union to market a new, highly sensitive diagnostic test for detection of hepatitis B surface antigen (HBsAg). The test is performed on Abbott’s ARCHITECT® system. Hepatitis B is an inflammatory liver disease caused by the hepatitis B virus…

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Raman supplement 2011

24 October 2011 | By

In this Raman supplement: Solid state transformations of APIS during manufacturing by Raman analysis of pharmaceutical molecules and dosage forms; Detection, determination of chemical composition and chemical profiling of counterfeit medicines...

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MALDI-mass spectrometry imaging applied to drug discovery and development

19 October 2011 | By Brendan Prideaux, Dieter Staab, Gregory Morandi, Nicole Ehrhard and Markus Stoeckli, Novartis Institutes for BioMedical Research

Since its introduction in the field of biomedical imaging over 10 years ago1, matrixassisted laser desorption/ionisation mass spectrometry imaging (MALDI-MSI) has played an ever increasing role in drug discovery and development and is now utilised in laboratories of many leading pharmaceutical companies and collaborating academic institutions.

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Detection of microorganisms using optical spectroscopic-based rapid method technologies

31 August 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the fourth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Previously, we discussed a number of cellular-component rapid microbiological methods (RMMs), such as ATP bioluminescence, fatty acid analysis, MALDI and SELDI time of flight mass spectrometry, Fourier transform-infrared…

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Thermodynamics and kinetics driving quality in drug discovery

31 August 2011 | By Geoff Holdgate, AstraZeneca

Recently, there has been renewed interest in using thermodynamic and kinetic data, alongside empirical rules (particularly focused upon cLogP and molecular weight) and guiding metrics such as ligand efficiency and lipophilic ligand efficiency developed for fragments, leads and drugs in order to facilitate the design of compounds with a greater…

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Thermo Fisher Scientific introduces Workflows at AACC 2011

26 July 2011 | By

Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today introduced a comprehensive range of clinical research and diagnostic products at the annual conference of the American Association for Clinical Chemistry (AACC). From automated sample handling to innovative sample analysis and storage solutions, ThermoFisher provides an integrated approach…