Special editions & supplements

PAT Supplement 2011 Front Cover

PAT supplement (free to view)

15 December 2011
The historical development of the FDA's PAT initiative and its present course (Terry McMahon, PAI Partners)
Implementation of modelling approaches in the QbD framework: Examples from the Novartis experience (Dr. Marianna Machin, Dr. Lorenz Liesum and Dr. Antonio Peinado, Novartis Pharma AG)
Challenges in development and implementation of spectroscopic techniques as PAT Analysers (Ravindra Dhumal and Tim Gough, Centre for Pharmaceutical Engineering Science, University of Bradford)

Rapid Methods Supplement 2011

Rapid Methods supplement (free to view)

24 October 2011
A regulators view - Bryan S. Riley, Senior Review Microbiologist, Office of Pharmaceutical Science, FDA – CDER
Microbiology series: Nucleic acid and gene amplification-based technologies - Michael J. Miller, President, Microbiology Consultants, LLC
Challenges and strategies for application in the pharmaceutical industry - Youwen Pan, Technology Resources / Sterility Assurance, Baxter Healthcare Corporation

Raman Supplement 2011

Raman supplement (free to view)

24 October 2011
Solid state transformations of APIS during manufacturing by Raman analysis of pharmaceutical molecules and dosage forms - Alain Hédoux, University Lille Nord de France
Detection, determination of chemical composition and chemical profiling of counterfeit medicines - Klara Dégardin, F. Hoffmann-La Roche & Institute of Forensic Science, University of Lausanne, Yves Roggo, F. Hoffmann-La Roche, Pierre Margot & Frederic Been, Institute of Forensic Science, University of Lausanne

Genomics Sequencing supplement

Genomics / Sequencing supplement (free to view)

31 August 2011
NGS powers up drug discovery and healthcare (Bhupinder Bhullar, Novartis Pharma AG), Impact of novel sequencing technology on transcriptome analysis (Wei Chen, Max Delbrück Center for Mollecular Medicine Berlin-Buch), Making sense of nonesense (and missense): Bringing the results of recent genetic studies into the drug discovery laboratory (Stephen A. Haney, Biological Profiling, Applied Quantitative Genotherapeutics, Pfizer Biotechnologies Unit), Show previews (Next Generation Sequencing Congress 2011, MipTec 2011)

eLN supplement

eLN supplement (free to view)

31 August 2011
Introduction: eLNs - An essential productivity tool - but which one to use? (John Wise, Executive Director, Pistoia Alliance)
Using an eLN to create GMP compliant records for drug substance manufacture (John Leonard, David Fletcher, Matthew Harrison and Ian Menzies, Pharmaceutical Development, AstraZeneca)
Implementation of an electronic lab notebook system at VIB (Alexander Botzki, eLN Project Officer, VIB)
eLN sponsors roundtable (featuring Accelrys, IDBS, AgileBio, Agilent, LabWare Europe, Waters)