【正文】 tradition. Their oversight of this third edition is work that their mentor would be highly pleased and proud of. From 29 chapters in the second edition to 43 chapters in this new edition, this threevolume series prehensively covers both the traditional subjects in parenteral science and technology as well as new and expanded subjects. For example, separate chapter topics in this edition not found in previous editions include solubility and solubilization, depot delivery systems, biophysical and biochemical characterization of peptides and proteins, container closure integrity testing, water systems, endotoxin testing, focused chapters on different sterilization methods, risk assessment in aseptic processing, visual inspection, advances in injection devices, RNAi delivery, regulatory considerations for excipients, techniques to evaluate pain on injection, product specifications, extractables and leachables, process analytical technology, and quality by design. The editors have done an outstanding job of convincing so many top experts in their fields to author these 43 chapters. The excellent reputations of the authors and editors of this book will guarantee superb content of each chapter. There is no other book in the world that covers the breadth and depth of parenteral science and technology better than this one. In my opinion, the editors have achieved their primary objectives—publishing a book that contains current and emerging sterile product development and manufacturing information, and maintaining the high standard of quality that readers would expect. Michael ]. Akers Baxter BioPhamia Solutions Bloomington, Indiana, .This page intentionally left blankPreface Pharmaceutical Dosage Forms: Parenteral Medications was originally published in 1984 and immediately accepted as a definitive reference in academic institutions and the pharmaceutical industry. The second edition was published in 1993. The ensuing years have produced incredible technological advancement. C lassic smallmolecule drugs are now plemented by plex molecules such as monoclonal antibodies, antibody fragments, aptamers, antisense, RNAi therapeutics, and DNA vaccines. There have been significant innovations in delivery devices, analytical techniques, insilico modeling, and manufacturing and control technologies. In addition, the global regulatory environment has shifted toward greater emphasis on sciencebased risk assessment as evidenced by the evolving cGMPs, quality by design (QbD), process analytical technology (PAT), continuous processing, real time release, and other initiatives. The rapidly changing landscape in the parenteral field was the primary reason we undertook the challenging task of updating the three volumes. Our objectives were to (/39。D Microbiology, Hospira, Inc., Lake Forest, Illinois, . Bob Helt Jacobs Engineering Group, Inc., Conshohocken, Pennsylvania, . Beth Holden Jacobs Engineering Group, Inc., Conshohocken, Pennsylvania, . Maik W. Jornitz Sartorius Stedim North America, Inc., Bohemia, New York, . Joseph J. Manfredi GMP Systems, Inc., Fairfield, New Jersey, . Christine Martin Abbott GmbH amp。 Dosage Forms: Parenteral Medications Third Edition Volume 2: Facility Design, Sterilization and Processing Edited by . Sandeep Nema healthcare John D. Ludwig Pharmaceutical Dosage FormsThis page intentionally left blankPharmaceutical Dosage Forms Parenteral Medications Third Edition Volume 2 Facility Design, Sterilization and Processing Edited by Sandeep Nema Pfizer, Inc. Chesterfield, Missouri， . John D. Ludwig Pfizer， Inc. Chesterfield, Missouri， . informa healthcare First published in 1984 by Marcel Dekker, Inc., New York, New York. This edition published in 2010 by Informa Healthcare, Telephone House, 6977 Paul Street, London EC2A 4La UK. 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