- Determination of Minor Quantities of Polymorph in Drug Substance: Comparison of Near-Infrared Spectroscopy and X-ray Powder Diffraction
Anthony Severdia, Satej Bhandarkar, Daniel Fogarty & William Rocco Sanofi-aventis US R&D
- Application of Online Reaction Monitoring by Raman and Infrared Spectroscopy in Early Drug Development: Halogen-Lithium Exchange Chemistry
Shelly Li, Ph.D. Pfizer Inc
- CMC Microbiology Review of Biologics License Applications and Pre-License/Pre-Approval Inspections: Therapeutic Biological Proteins
Anastasia G. Lolas, Bo Chi, Ph.D., Patricia F. Hughes, Ph.D. & Kalavati Suvarna, Ph.D. Biotechnology Manufacturing Team Division of Manufacturing and Product Quality Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration
- Extemporaneous Formulations: Comparison with Labeled Pediatric Formulations
Karen C. Thompson, Ph.D. Merck Research Laboratories
- Functionality and Performance of Excipients in Quality-by-Design World, Part VIII: Excipient Specifications
Chris Moreton, Ph.D. FinnBrit Consulting
- Small Particles, Large Scale: An Efficient Platform for Open-Access Fast LC on a Global Scale
James M. Roberts, Ph.D., Steve R. Cole, Ph.D., Jay Spadie, Helen E. Weston, William K. Young, Ph.D. GlaxoSmithKline
- Thermal Analysis – A Review of Techniques and Applications in the Pharmaceutical Sciences
Steven P. Stodghill, Ph.D. Belmont University School of Pharmacy
- Trends in Lyophilization: Review of the Recent Lyophilization Conference on Ensuring Optimum Formulations for Biologics
Nicholas W. Warne, Ph.D. BioTherapeutics Pharmaceuticals Research and Development Pfizer
- Pharmaceutical Salts Optimization of Solubility or Even More?
Christoph Saal, Ph.D. Merck KGaA
- Plastic Pre-fillable Syringes and Vials: Progress Towards a Wider Acceptance
Michael N. Eakins, Ph.D. Principal Consultant, Eakins & Associates
