- A Novel Approach to Determining Particle Size Distributions of Pharmaceutical Powders by Near Infrared Spectroscopy
Chunsheng Cai, Ph.D. and David Radspinner, Ph.D.
Sanofi-Aventis
- An Approach to Automated Parallel LC-MS/MS in Drug Discovery
Ellen Tasker, Paul Desmond, Ph.D., Patrick Currie, James Baker, Ph.D., and Stuart Best, Ph.D.
Organon Research Scotland
- Basic Guidelines for Building a New GLP Bioanalytical Laboratory - Part 1: Reasons to Build a Lab, the Master Plan, and SOPs
Adam Brockman and Jing-Tao Wu
Millennium Pharmaceuticals
- Biopharmaceutical Stability Studies: Stable Vaccine Dosage Form Development for Commercial Use
Li Shi, Patricia A. DeHaven, and Carl J. Burke
Merck Research Laboratories
- Critical Roles of Porosity in Tableting Properties Characterization and Solids Formulation Development
Changquan Calvin Sun, Ph.D.
Pfizer, Inc.
- Development and Implementation of an In-Line Quantitative Raman Method for In-Process Pharmaceutical Monitoring
Robert Wethman, Charles Ray, Ph.D. and John Wasylyk, Ph.D.
Analytical R&D
Bristol-Myers Squibb
- Electrical Conductivity Analysis/Dielectric Analysis Differentiates Physical-Chemical Properties of Drugs and Excipients
aAlan T. Riga and bKenneth S. Alexander
aDepartment of Chemistry, Cleveland State University
bCollege of Pharmacy Practice, Wolfe Hall, University of Toledo
- Fast Dynamics as a Diagnostic for Excipients in Preservation of Dried Proteins
Marcus T. Cicerone
National Institute of Standards and Technology
- Functionality Testing of Excipients and Their Impact on Formulation Development
Ganapathy Mohan, Ph.D.
Global Analytical Sciences Department
Sanofi-Aventis Pharmaceuticals
- Future Trends in LIMS
R.D. McDowall, Ph.D.
McDowall Consulting
- ISO 14644 Air Cleanliness Standards for a Large-Scale Aseptic Manufacturing Facility
Miguel Montalvo
Vice-President, Validation Compliance
AAC Consulting Group, Inc.
- Particle Size Measurement Technique Selection Within Method Development in the Pharmaceutical Industry
Richard N. Kelly, Ph.D. and Susan A. Lerke, Ph.D.
Johnson & Johnson Pharmaceutical Research & Development
- Risk-Based Approaches Facilitate Expedient Validations for Control of Microorganisms During Equipment Cleaning and Hold
Edward C. Tidswell, BSc, Ph.D.
Eli Lilly & Company
- Selection of Analytical Techniques for Pharmaceutical Leachables Studes
Qingxi Wang, Ph.D.
Merck & Company, Inc.
- The Business of Biomarkers in Pharmaceutical Development
David S. Lester and Joe Alexander, Jr., M.D., Ph.D.
Pfizer, Inc.