American Pharmaceutical Review: A Russell Publishing Publication

July/August 2005

Articles

• Analytical Laboratories Need an Integrated IT Solution

  Joseph Kofman, Ph.D., Todd Baumgartner, Alan P. Levis
  Pfizer Global Research and Development

• Assessing the Biological Safety of Extractable and Leachable Chemicals in Pharmaceutical and Medical Products

  Sharon J. Northup, Ph.D., DABT
  Northup Regulatory Toxicology Services

• Laboratory Automation in Phase I Development

  K. Rick Lung, Ph.D., Joshua T. Ayers, Ph.D., Christy Yembrick, and Peter Guerrieri
  Pharmaceutical and Analyutical R&D - Wilmington
  AstraZeneca Pharmaceuticals LP

• Polymorphism: Thermodynamic and Kinetic Factors to be Considered in Chemical Development, Part 1

  Danielle Giron
  Chemical and Analytical R&D
  Novartis Pharma

• Radiosensitivity Study of Glucose and Trehalose to Gamma Irradiation

  Caballero I.¹, Castillo A.¹, Naydenov V.², Tilquin B.^{2
  1}Center of Molecular Immunology
  ²Universite Catholique de Louvain, Faculte de Medecine

• Raman Imaging Microscopy - A Potential Cost-effective Tool for Drug Development

  Jian Ling, Ph.D.
  Southwest Research Institute

• Rational Excipient Selection for Enhanced Tablet Properties at Small Formulation Scale - Case Study of Compaction Simulator Application in Early Phase Tablet Formulation Development

  Xi-Yong (Sean) Fu, Feng Li, Steve Galen, Ashkan Kamali, Maria Cruanes, and Sami Karaborni
  Merck & Company

• Strategies for Managing Environmental Monitoring Investigations

  Robert Westney, RAC
  Quality Control Manager
  MedImmune Vaccines, Inc.

• Technologies and Standards Used in the Measurement of DNA Biomarkers for the Safety of Tissue-Engineered Medical Products

  Henry Rodriguez, Ph.D., MBA
  Leader, Cell and Tissue Measurements Group
  Biotechnology Division, National Institute of Standards and Technology

• Terminal Sterilization and Potential for Parametric Release

  Radhakrishna Tirumalai, Ph.D. and David Porter, Ph.D.
  US Pharmacopeia