American Pharmaceutical Review: A Russell Publishing Publication

January/February 2008

Articles

• Cutting Edge Technologies and their Potential Role in Pharmaceutical Microbiology

  Andrew M Middleton

• Polyphasic Approach to Microbial Identification

  Hans-Joachim Anders, Marion Keller, Manfred Berchtold and Werner HeckerBiological and Microbiological ServicesNovartis Pharma Stein AG

• Review of Pharmaceutical Product Stability, Packaging and the ICH Guidelines

  Ghulam A. Shabir, Ph.D. Abbott Diabetes Care, Abbott Laboratories

• Chemical and Physical Stability Considerations for Lipid-based Drug Formulations

  John B. Cannon, Ph.D. Targeted Drug Solutions Inc.

• Tumor Angiogenesis Imaging with CT Perfusion

  Ting-Yim Lee, PhD, Jim Xuan, PhD, Glenn Bauman, MD, Eugene Wong, PhD, Peter Gabra, BSc, Lawson Health Research Institute, Robarts Research Institute, Departments of Diagnostic Radiology & Nuclear Medicine,Medical Biophysics, Surgery, Oncology and Physics, The University of Western Ontario

• Current Practice and Future Strategies for Viral Clearance in mAb Downstream Production

  Joe X Zhou and Tim Tressel Department of Purification Process Development, Amgen Inc.

• PAT for the Product Lifecycle of a Biopharmaceutical Product

  Ronan O’Kennedy Biopharmaceutical Process Development, Biopharmaceutical CEDD GlaxoSmithKline

• Application of LC-MSn in Conjunction with Mechanism-based Stress Studies in the Elucidation of Drug Impurity/Degradation Product Structures and Degradation Pathways

  Min Li, Ph.D., Bin Chen, Ph.D., Mingxiang Lin, Ph.D., and Abu Rustum, Ph.D., Global Quality Services – Analytical Sciences Schering-Plough Corporation

• Applicability of the “Threshold of Toxicological Concern” Concept to Residue Limits for Cleaning Validation

  Destin A. LeBlanc Cleaning Validation Technologies

• Where Does the Responsibility Begin and End for Extractables and Leachables Testing of Single Use Technologies? Customer and Supplier Responsibilities

  Karen Wright Novartis Vaccines

• Container Closure Systems and Parenteral Products Life Cycle

  Mihaela Simianu, Ph. D. Eli Lilly and Company

• Identity Testing of Raw Materials for Pharmaceutical Production by Raman Spectroscopy

  A. Kirsch, S. Scheufens, C. Saal, Merck KGaA, Frankfurter Strasse 250

• Monitoring Polymorphism of Drugs, an On-Going Challenge - Part 1

  Danielle Giron Novartis Pharma AG

• A Spoonful of Sugar; Taste Masking Strategies in Pharmaceutical Product Development - Part 2

  David T. Rossi and John N. Twist R & D Strategic Planning Mylan Pharmaceuticals

• Comprehensive Chiral HPLC Method Development for Pharmaceutical Compounds During Late Stage Development

  Brian Lingfeng He and Yueer Shi Analytical R&D, Research and Development Bristol-Myers Squibb