American Pharmaceutical Review: A Russell Publishing Publication

November/December 2009

Articles

• Pharmaceutical Counterfeiting: Unique Challenges for the Analytical Laboratory

  Scott Huffman & Lydia Breckenridge Bristol-Myers Squibb

• Developing an Appropriate Salt Form for an Active Pharmaceutical Ingredient

  Harry G. Brittain, Ph.D. Center for Pharmaceutical Physics

• New Developments in Scale-Up and QbD to Ensure Control Over Product Quality

  Martin Bohlin Ph.D., Helen Jones Ph.D., & Simon Black Ph.D. Global Process R&D, AstraZeneca

• Functionality and Performance of Excipients in Quality-by-Design World Part VI: Excipient Composition

  Chris Moreton FinnBrit Consulting

• The BET as a Backdrop for Establishing PAT and RMM Goals

  By Kevin L. Williams Eli Lilly & Company

• Biophysical Approaches to the Detection and Characterization of Particles in an Antibody Solution

  Sorina Morar-Mitrica Ph.D., Charlene Brisbane, Douglas Nesta Ph.D. & Amol Ketkar Ph.D. GlaxoSmithKline

• A Systematic Approach to Convert Ultra-Fast HPLC Conditions to Conventional HPLC Conditions

  Xiaowei Sun Principal Research Scientist Wyeth Research Loren Wrisley Director of Analytical and Quality Sciences Wyeth Research

• Quality-by-Design as Applied to the Development and Manufacturing of a Lyophilized Protein Product

  Feroz Jameel, Ph.D. Drug Product Device Development Amgen Inc Mansoor Khan, Ph.D. Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research,Food and Drug Administration, MD.

• Practical Considerations on PAT Analyzer Selection - Raman vs. NIR Spectroscopy

  Saly Romero-Torres, Ph.D., Jun Huang, Ph.D., & Pedro E. Hernandez-Abad, Ph.D. Wyeth Pharmaceuticals