American Pharmaceutical Review: A Russell Publishing Publication

July/August 2006

Articles

• A Critical Approach to the Evaluation of Packaging Components and the Regulatory and Scientific Considerations in Developing a Testing Strategy

  C. Jeanne Taborsky, President, SciRegs International, Inc., Eric B. Sheinin, Ph.D., USP Fellow, United States Pharmacopeia, and Desmond G. Hunt, Ph.D., Senior Scientific Associate, United States Pharmacopeia

• Analysis of Residual Metals and Organometallics in Pharmaceuticals by High Performance Liquid Chromotography with Inductively Coupled Plasma Mass Spectrometry (HPLC-ICP-MS)

  Matthew A. Lorenz, Daphene D. Wang, Peter D.A. Angus, Pharm D., Ph.D.
  Pfizer Global Research and Development

• Applying Selective Biophysical Techniques in Assessing the Comparability of Protein Therapeutics - Case Studies

  Yijia Jiang, Ph.D. and Linda Owers Narhi, Ph.D.
  Amgen, Inc.

• Characterizing Water States in Microemulsions Using Sub-Ambient Differential Scanning Calorimetry

  Jerry Nesamony, Ph.D., University of Appalachia College of Pharmacy
  Rahul V. Manek, Ph.D., Rigel Pharmaceuticals, Inc.
  William M. Kolling, Ph.D., School of Pharmacy, Southern Illinois University Edwardsville

• Computer System Validation in Research and Development Environment

  Boris Gorovits, Frank Barlleta, Nicholas Molinaro
  Wyeth Research

• Efficiency with Rapid Microbiology Methods

  Manish Ghandi, M.S.
  Leiner Health Products

• Implementation of Microbial Environmental Monitoring Program for Non-Aseptic Pharmaceutical Processes

  Angel L. Salamán-Byron, Ph.D.
  Wyeth Pharmaceutical Company

• Of Mice and Men: Multimodality Imaging of Disease Models

  Thomas Krucker, Ph.D.
  Novartis Institute for BioMedical Research

• Prioritizing Molecules for Development Based on Physico-Chemical Characteristics

  Dr. Christian Schröter
  Merck KGaA

• Rapid Content Uniformity Determination of Low Dose TCH346 Tablets by Nir

  Qin Ji, Ph.D., Venkat Tumuluri, Wei Wang, Jason Teelucksingh, Mark Mecadon, Raju Vegesna, Ph.D.
  Novartis Pharmaceuticals Corporation, Pharmaceutical and Analytical Research and Development

• Rapid Screening of UV Absorbing Leachables in Biologic Product Placebos

  Anneli DePaolis, Ph.D., Lin Zhu, Ph.D., Srinivas Gunturi, Ph.D., Fengxia Deng, Ph.D., Selima Begum, Ph.D., Glen Tolman, Ph.D., Tom Templeman, Ph.D., and Ibrahim Ghobrial, Ph.D.
  Pharmaceutical Sciences, GBSC, Centocor

• Viral Clearance: Innovative Versus Classical Methods - Theoretical and Practical Concerns

  Joe X. Zhou, Ph.D. and Houman Dehghani, Ph.D.
  Amgen, Inc.