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

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.

Volume 3: CGMP Regulations of Parenteral Drugs Terry E. Munson Risk Assessment and Mitigation in Aseptic Processing James Agalloco and James Akers Validation of Drug Product Manufacturing Processes: NCEs and NBEs Karoline Bechtold-Peters Visual Inspection Maria Toler and Sandeep Nema Advances in Parenteral Injection Devices and Aids Donna L. French and James J. Collins, Jr. SiRNA Targeting Using Injectable Nano-based Delivery Systems Lan Feng and Russell J. Mumper Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls Sandeep Nema Techniques to Evaluate Damage and Pain on Injection Gayle A. Brazeau, Jessica Klapa and Pramod Gupta Parenteral Product Specifications and Stability Michael Bergren Extractables and Leachables Edward Smith and Dianne M. Paskiet Process Analytical Technology and Rapid Microbial Methods Geert Verdonk and Tony Cundell Quality AssuranceMichael Gorman Application of Quality by Design in CMC Development Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh Future of Parenteral Manufacturing James Agalloco, James Akers, and Russell Madsen

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.