Parenteral Medications • Volume 3 is a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production.

Features:

• An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables
• Specific chapters on parenteral administration devices, injection site pain assessment, and parenterall 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, process analytical technology and rapid microbiological methods, and validation of drug product manufacturing process

Contents

1. cGMP regulations of parenteral drugs
2. Risk assessment and mitigation in aseptic processing
3. Development challenges and validation of fill and finish processes for biotherapeutics
4. Visual inspection
5. Advances in parenteral injection devices and aids
6. siRNA targeting using injectable nano-based delivery systems
7. Excipients for parenteral dosage forms: regulatory considerations and controls
8. Techniques to evaluate damage and pain on injection
9. Parenteral product speficications and stability
10. The management of extractables and leachables in pharmaceutical products
11. Process analytical technology and rapid microbiological methods
12. Quality assurance
13. Application of Quality by Design in CMC development
14. Future of parenteral manufacturing

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