Pharmaceutical Dosage Forms - Parenteral Medications: Volume 3: Regulations, Validation and the Future, 3rd Edition (Hardback) book cover

Pharmaceutical Dosage Forms - Parenteral Medications

Volume 3: Regulations, Validation and the Future, 3rd Edition

Edited by Sandeep Nema, John D. Ludwig

CRC Press

326 pages | 90 B/W Illus.

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pub: 2010-08-26
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Description

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.

Table of Contents

Volume 3:

  1. CGMP Regulations of Parenteral Drugs
  2. Terry E. Munson

  3. Risk Assessment and Mitigation in Aseptic Processing
  4. James Agalloco and James Akers

  5. Validation of Drug Product Manufacturing Processes: NCEs and NBEs
  6. Karoline Bechtold-Peters

  7. Visual Inspection
  8. Maria Toler and Sandeep Nema

  9. Advances in Parenteral Injection Devices and Aids
  10. Donna L. French and James J. Collins, Jr.

  11. SiRNA Targeting Using Injectable Nano-based Delivery Systems
  12. Lan Feng and Russell J. Mumper

  13. Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls
  14. Sandeep Nema

  15. Techniques to Evaluate Damage and Pain on Injection
  16. Gayle A. Brazeau, Jessica Klapa and Pramod Gupta

  17. Parenteral Product Specifications and Stability
  18. Michael Bergren

  19. Extractables and Leachables
  20. Edward Smith and Dianne M. Paskiet

  21. Process Analytical Technology and Rapid Microbial Methods
  22. Geert Verdonk and Tony Cundell

  23. Quality Assurance

    Michael Gorman

  24. Application of Quality by Design in CMC Development
  25. Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh

  26. Future of Parenteral Manufacturing

James Agalloco, James Akers, and Russell Madsen

About the Editors

Sandeep Nema Ph.D. is Executive Director, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences at Pfizer in St. Louis. Since graduating in 1992 with his doctorate, Dr. Nema has been involved with the development of small molecule and protein drugs via parenteral delivery, first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia), and has led the formulation of four launched products. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA), where he has chaired several meetings and focus groups. Dr. Nema holds an adjunct faculty appointment at the University of Tennessee.

John D. Ludwig Ph.D. is Vice President, Business Strategy, Operations, and Clinical Supply Planning, BioTherapeutics Pharmaceutical Sciences at Pfizer, and Site Director for the company’s St. Louis Laboratories. Dr. Ludwig received a B.S. degree in Pharmacy and Ph.D. degree in Pharmaceutics from the University of Tennessee, Memphis and has held numerous research and development positions at Burroughs Wellcome Co, Searle, Inc., Pharmacia, Inc., and Pfizer. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA) Training and Research Institute, where he has contributed to developing professional training courses and has regularly served as an instructor.

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General