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

ISBN-13: 9781420086478 / Angielski / Twarda / 2009 / 326 str.

Sandeep Nema; John D. Ludwig

Opis

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume three presents: * 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.

Spis treści

Volume 3:

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