Article Information
PubMed
Published By
Print ISSN
Online ISSN
History
- Published online July 17, 2014.
Copyright & Usage
© PDA, Inc. 2014
Author Information
Cited By...
Jump to section
- Article
- Abstract
- Introduction
- U.S. and European Regulatory Agency Positions on Aseptic Processing Versus Terminal Sterilization
- Product Recalls and Warning Letters
- Categories of Product Generally Not Requiring Justification for Aseptic Processing
- Demonstration of the Heat Instability of a Sterile Drug Product During Pre-formulation
- Sterility Assurance Levels Achieved Using Terminal Sterilization and Aseptic Processing
- Review of Drug Substance and Drug Product Stability As Applicable To Sterile Product Development
- Conclusions
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
Cited By...
- No citing articles found.