Pharmaceutical Dosage Forms: Parenteral Medications, Third Edition: Volume 3: Regulations, Validation and the Future

Volume 3 provides:

• An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables.
• Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing.
• Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems.
• New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.

• 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