Descrição
CONTENTS:
1. cGMP Regulations of Parenteral Drugs – Terry E. Munson
2. Risk Assessment and Mitigation in Aseptic Processing – James Agalloco and James Akers
3. Validation of Drug Product Manufacturing Processes: NCEs and NBEs – Karoline Bechtold-Peters
4. Visual Inspection – Maria Toler and Sandeep Nema
5. Advances in Parenteral Injection Devices and Aids – Donna L. French and James J. Collins, Jr.
6. SiRNA Targeting Using Injectable Nano-based Delivery Systems – Lan Feng and Russell J. Mumper
7. Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls – Sandeep Nema
8. Techniques to Evaluate Damage and Pain on Injection – Gayle A. Brazeau, Jessica Klapa and Pramod Gupta
9. Parenteral Product Specifications and Stability – Michael Bergren
10. Extractables and Leachables – Edward Smith and Dianne M Paskiet
11. Process Analytical Technology and Rapid Microbial Methods – Geert Verdonk and Tony Cundell
12. Quality Assurance – Michael Gorman
13. Application of Quality by Design in CMC Development – Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh
14. Future of Parenteral Manufacturing – James Agalloco, James Akers, and Russell Madsen
