American Pharmaceutical Review: A Russell Publishing Publication

January/February 2004

Articles

• A Risk-Based Approach to Part 11

  Madeleine Kennedy, Ph.D.
  Eli Lilly & Company

• Challenges of Blend Uniformity Testing for Tablet Formulation

  Ruey-ching Hwang, Ph.D. and Sy-Juen Wu, Ph.D.
  Pfizer Inc.

• Detection of Polymorphism by Powder X-Ray Diffraction: Interference by Preferred Orientation

  M. Davidovich, J. Z. Gougoutas, R. P. Scaringe, I. Vitez, S. Yin
  Bristol-Myers Squibb Pharmaceutical Research Institute

• Direct Powder Blends for Encapsulation and Tablet Compression Part II: Materials

  John A. McCarty
  Pharmaceutical Productions, Inc.

• Important Parameters for Optimal Target Virus Clearance: Virus Spike Selection Issues

  Marina Korneyeva, Scott Rosenthal, Peter Charles, Samuel Trejo, Dominique Pifat, and Steve Petteway
  Bayer Corporation, Research and Development, Pathogen Safety Department

• Integration of Atmospheric Pressure Photoionization Interfaces to HPLC-MS/MS for Pharmaceuticals Analysis

  Yunsheng Hsieh, Ph.D. and Ganfeng Wang
  Drug Metabolism and Pharmacokinetics Department, Schering-Plough Research Institute

• Lyophilization Optimization Using DSC and MT-DSC

  A. Rameau, A. Chevalier, and C. Neves
  Applied Physics, Pharmaceutical Sciences, Paris Research Center
  Aventis Pharma

• Maintaining Change Control in Part 11 ­- Compliant Systems - ­ A Quality Systems Approach

  Peter Bland
  Senior Manager, Global Change Control, Genentech, Inc.

• Particle Size Analysis: A Comparison of Methods

  Frank M. Etzler, Ph.D.
  Boehringer-Ingelheim Pharmaceuticals

• Process Analytical Technology -­ Changing the Validation Paradigm

  Randall Schadt, Ph.D.
  Pfizer Global Manufacturing, Pfizer Inc.

• Raman Spectroscopy: A Technique for the Process Analytical Technology Toolbox

  Staffan Folestad and Jonas Johansson
  AstraZeneca PAT Center of Excellence, AstraZeneca R&D

• Regulatory Aspects Concerning the Quality Controls of Microbiological and Non-viable Particulate Contamination in Pharmaceutical Manufacturing

  Ray T. Oji
  Food and Drug Administration

• Roller Compaction: A PAT Application Using Near-Infrared In-Process Mapping, Monitoring and Characterization

  Ronald W. Miller, Ph.D.
  Global Pharmaceutical Technology, Bristol-Myers Squibb
  Abhay Gupta
  Graduate Student, IPPH Purdue University School of Pharmacy

• Solid-State NMR Spectroscopy of Pharmaceutical Materials

  Thomas J. Offerdahl and Eric J. Munson*
  The University of Kansas
  *Author to whom correspondence should be addressed

• The Impact of Process Analytical Technology (PAT) On Pharmaceutical Manufacturing

  Rick E. Cooley and J. Carmel Egan, Ph.D.
  Eli Lilly and Company