American Pharmaceutical Review: A Russell Publishing Publication

May/June 2009

Articles

• Quality by Design in the Pharmaceutical Industry:

  Theodora Kourti, PhD.

• Molecular Imaging in Oncology Drug Development:

  Dr. Helen Young, Ph.D. Senior Imaging Scientist

• Biowaivers in the United States, European Union, and Japan

  Gregg Kelly, Ph.D., Pfizer

• Risk Management Strategies for Safety Qualification of Extractable and Leachable Substances in Therapeutic Biologic Protein Products

  Ingrid Markovic, Ph.D., U.S. Food and Drug Administration, Center for Drug Evaluation and Research

• A Systematic Approach to RP-HPLC Method Development in a Pharmaceutical QbD Environment

  Yan Li, Ph.D., Gerald J Terfloth, Ph.D. & Alireza S Kord, Ph.D., Analytical Sciences, Chemical Development, GlaxoSmithKline

• Micrometer Sized Particles Seen Through the Lens of a Microscope:

  Arjen P. Tinke, Ph.D., Ilse Weuts, Ph.D. & Koen Vanhoutte, Ph.D., Johnson & Johnson Pharmaceutical Research and Development

• From Syringe to Autoinjector

  Robin Hwang, Ph.D. & Dennis Murphy, formerly from Amgen

• Strategies for Handling Impurities in Excipients:

  Sreevalsan Divakar, Jazz Pharmaceuticals

• Application of PAT to API Synthesis from R&D to Manufacturing

  Darryl J. Ertl, Susan E. Barnes, Ph.D., Bob E. Cooley & Charles A. Goss, Ph.D.

• Model for Raman Spectroscopic Monitoring of Process-Induced Pseudomorph Interconversion

  Yong Zhou, Ph.D., Nicole Crane, Ph.D.,Chunsheng Cai, Ph.D. & Yanxi Tan Cain, Ph.D., Global Quality Analytical Development – New Products, Wyeth Pharmaceuticals

• Challenges in the Determination of Water Content by Karl Fischer Titration During In-Process Control

  Qian Chen, Ph.D. & Yuwen Wang, Ph.D., Boehringer Ingelheim Pharmaceuticals, Inc.

• Consensus Rating Methods for Small and Large Virus-Retentive Filters

  Richard Levy, Ph.D., Parenteral Drug Association (PDA)

• Multi-Component Biopharmaceuticals in a Closed, Single-Use System

  Kirsten Strahlendorf & Kevin Harper

• Functionality and Performance of Excipients in a Quality-by-Design World. Part 3:

  Chris Moreton, Ph.D.

• Nucleic Acid Amplification – Based Rapid Microbiological Methods:

  Claudio D. Denoya, Ph.D, Microbiological Technical Assessment Group Parenteral Center of Emphasis,