Pharmaceutical Dosage Forms - Parenteral Medications

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.

Volume 2: Asceptic Manufacturing Facility Design Mark Caldwell, Bob Helt, Beth Holden, Francesca McBride, and Kevin Schreier Personnel and their impact on Cleanroom Operations Jeanne Moldenhauer The Fundamentals of an Environmental Control Program William H. Miele Water Systems for Parenteral Facilities J. Manfredi Particulate Matter: Sub-Visible D. Scott Aldrich Endotoxin Testing Michael E. Dawson The Compendial Sterility Tests Scott VW Sutton Industrial Sterilization Technologies: Principles and Overview Anne F. Booth Steam Sterilization James Agalloco Gas, Vapor and Liquid Chemical Sterilization James Agalloco Dry Heat Depyrogenation and Sterilization Deborah Havlik and Kevin Trupp Radiation Sterilization Barry P. Fairand and Dusan Razem Filters and Filtration Maik W. Jornitz and Theodore H. Meltzer Processing of Small Volume Parenterals (SVPs) and Large Volume Parenterals (LVPs) Donald A. Eisenhauer, Christine Martin, Roland Schmidt, and Steven G. Schultz Freeze Drying: Principles and Practice Steven L. Nail and Larry A. Gatlin