American Pharmaceutical Review: A Russell Publishing Publication

May/June 2006

Articles

• Blow-Fill-Seal(BFS) Sterility Assurance Validation(SAV) - Saving Time and Pain on Your SAV

  Robert J. Wherry
  Sepracor, Inc.

• Examining the Range of Methods Available to Derive Numerous Polymorphic Forms

  Michael Maiwald
  Merck KGaA

• Influence of Particle Size and Shape on the Drug Product - Aspects of Formulation and Performance

  Kai Jurgens
  Schering AG

• Media Fills: Special Considerations for Clinical Manufacturing

  Sarah Doshna
  Bristol-Myers Squibb

• Quantification of Polymorphic Forms by Raman Spectroscopy

  Christop Saal
  Merck KGaA

• Quantitative HPLC Tandem Mass Spectrometry (LC/MS/MS) Analysis of Low-Level Impurities in Active Pharmaceutical Ingredients

  Eugene P. Kadar, Gregg R.D. Kelly, Andrew Blanchard, Charles Palmer, Tyrone Shire, Henry J. Yorzinski, and Zhongli Zhang
  Pfizer Global Research & Development

• Securing Your System for Part 11 Compliance

  Elien Young
  Novartis Pharmaceuticals

• Seeing Beyond Calipers: Small Animal Imaging and Pre-Clinical Evaluation of Cancer Drug Candidates

  ¹Mac Johnson, Matthew Silva, Donna Cvet, Sudeep Chandra, and ²Erik Kupperman, Corinne Reimer, Rob Roberston
  ¹Imaging Sciences and ²Cancer Pharmacology
  Millennium Pharmaceuticals

• Speeding Development of Poorly Soluble/Poorly Permeable Drugs by SEDDS/S-SEDDS Formulations and Prodrugs (Part II)

  Ping Gao, Amgen, Inc.
  Marvin Charton, Pratt Institute
  Walt Morzowich, formerly of Pfizer, currently, Prodrug/Soft Drug Consultant

• State-of-the-Art Immunological Methods Used During the Non-Clinical Safety Assessment of Vaccines

  Abu B. Siddique, Ph.D. and Jose A. Lebron, Ph.D.
  Discovery and Biologics Safety Assessment, Merck Research Laboratories

• The Impact of Stopper Drying for Lyophilized Drug Products

  Andreas Abend, Ph.D., Allen Templeton, Ph.D., and Robert Reed, Ph.D.
  Merck & Company

• The Proper Role of Environmental Monitoring in Aseptic Processing

  Jim Akers
  Akers, Kennedy & Associates, Inc.

• Thermal Analysis of Supramolecular Systems: Characterization of Water-Soluble, Calixarene-Drug Complexes

  ¹Wenzhan Yang and ²Melgardt M. de Villiers
  ¹AstraZeneca
  ²School of Pharmacy, University of Wisconsin - Madison

• Top Five Challenges Facing Pharmaceutical Microbiologists

  Tony Cundell, Ph.D.
  Consulting Microbiologist