American Pharmaceutical Review: A Russell Publishing Publication

May/June 2005

Articles

• Evaluation of Crystallizaton Kinetics of Amorphous Sulfapyridine by DSC

  B. DattaChowdhury¹, K.S. Alexander¹, A.T. Riga¹, K. Chatterjee^{2*
  1}Department of Pharmacy Practice, University of Toledo
  Drug Product Process Development, Amgen, Inc.

• Extractables and Leachables: A Biopharmaceutical Perspective

  Stuart Green
  Centocor, Inc.

• Lyophilization - Points to Consider for Successful Process Transfer to Manufacturing

  Stelios C. Tsinontides, Ph.D.
  Merck & Company

• Material of Construction for Biopharmaceutical Water Systems, Part 1

  Michelle M. Gonzalez
  Principal Engineer Corporate Engineering and Captial Projects
  Amgen, Inc.

• New Dimensions in Pharmaceutical Diagnostics

  Dor Ben-Amotz, Ph.D.
  Purdue University, Department of Chemistry

• New Image Analysis Approach for Particle Size Monitoring of Pharmaceutical Solids

  Dr. Niklas Sandler
  Senior Researcher, Division of Pharmaceutical Technology
  University of Helsinki-Finland

• Raising Both Ends of the EM Bar

  Ray Cardin
  Genzyme Corporation

• Regulatory Aspects of X-ray Powder Diffraction, Part 1

  Stephen R. Byrn, Ph.D., Simon Bates, Ph.D. and Igor Ivanisevic, Ph.D.
  Department of Industrial and Physical Chemistry
  Purdue University

• Regulatory Considerations for Stability Indicating Analytical Methods in Drug Substance and Drug Product Testing

  Michael J. Smela, Jr.
  FDA-CDER

• Review of Lipids in Pharmaceutical Drug Delivery Systems, Part 1

  Hemant N. Joshi, Ph.D., MBA¹and Navnit Shah, Ph.D.^{2
  1}Barr Laboratories
  ²Hoffmann La-Roche

• Strategies for Developing a Successful Electronic Submission

  Guy Pawson
  Manager, Development eSubmissions
  Genentech, Inc.

• The Role of USP Microbiology Standards and Information in the Development, Formulation, Manufacturing, and Marketing of Drugs and Biologicals

  Roger Dabbah, Ph.D.
  Department of Standards Development
  U.S. Pharmacopeia