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

3rd Edition

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

Edited By Sandeep Nema, John D. Ludwig Copyright 2010
326 Pages 90 B/W Illustrations
by CRC Press

326 Pages 90 B/W Illustrations
by CRC Press

318 Pages
by CRC Press
Also available as eBook on:
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... Read more

Volume 3:

  1. CGMP Regulations of Parenteral Drugs

    2. Terry E. Munson

  2. Risk Assessment and Mitigation in Aseptic Processing

    3. James Agalloco and James Akers

  3. Validation of Drug Product Manufacturing Processes: NCEs and NBEs

    4. Karoline Bechtold-Peters

  4. Visual Inspection

    5. Maria Toler and Sandeep Nema

  5. Advances in Parenteral Injection Devices and Aids

    6. Donna L. French and James J. Collins, Jr.

  6. SiRNA Targeting Using Injectable Nano-based Delivery Systems

    7. Lan Feng and Russell J. Mumper

  7. Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls

    8. Sandeep Nema

  8. Techniques to Evaluate Damage and Pain on Injection

    9. Gayle A. Brazeau, Jessica Klapa and Pramod Gupta

  9. Parenteral Product Specifications and Stability

    10. Michael Bergren

  10. Extractables and Leachables

    11. Edward Smith and Dianne M. Paskiet

  11. Process Analytical Technology and Rapid Microbial Methods

    12. Geert Verdonk and Tony Cundell

  12. Quality Assurance
    Michael Gorman

  13. Application of Quality by Design in CMC Development

    14. 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

Biography

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.

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