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Preface Foreword List of Contributors 1 Parenteral Dosage Forms: Introduction and Historical Perspective John D Ludwig 2 Parenteral Drug Administration: Routes of Administration and Devices Himanshu Bhattacharjee, Vivian Loveless, and Laura A Thoma 3 Dosage and Administration Instructions for Parenteral Medications: Stability, Compatibility, Coadministration, and Microbiology S Kay and D Man 4 Autoinjector and Pen Devices: Combination Product Design and Use Scott Gibson 5 Preformulation N Murti Vemuri, Abira Pyne Ramakrishnan 6 Preformulation of New Biological Entities Riccardo Torosantucci, Vasco Filipe, Jonathan Kingsbury, Atul Saluja, and Yatin Gokarn 7 Clinical Pharmacology of Parenteral Dosage Forms Anis A Khan and Lorin K Roskos 8 Excipients for Parenteral Use Sandeep Nema and Ronald J Brendel 9 Drug Solubility and Solubilization Ching-Chiang Su, Lan Xiao, and Michael J Hageman 10 Formulation Development of Small- and Large-Volume Parenteral Products Madhav S Kamat and Patrick P DeLuca 11 Formulation of Protein- and Peptide-Based Parenteral Products Gaozhong Zhu and Pierre O Souillac 12 Biophysical and Biochemical Characterization of Peptide, Protein, and Bioconjugate Products Tapan K Das and James A Carroll 13 Development of Ophthalmic Formulations Paramita Sarkar, Martin Coffey, and Mohannad Shawer 14 Formulation Development of Prophylactic and Therapeutic Vaccines Antu Dey and Manmohan Singh 15 Techniques to Evaluate Damage and Pain on Injection Srinidi Mohan, Gayle A Brazeau, and Pramod Gupta 16 Design and Delivery of Antibody-Drug Conjugates Alavattam Sreedhara 17 Unique Chemistry, Manufacturing, and Controls Challenges and Expectations in the Development of Biosimilars Carol Kirchhoff, Chee-Keng Ng, Arindam Bose, and Beverly Ingram 18 Formulation of Depot Delivery Systems Christopher A Rhodes and Nikita Malavia 19 Active Nanoparticle Targeting: Current Status and Future Challenges Siddharth Patel and Janni Mirosevich 20 Cellular Therapeutics: A Novel Modality with Great Therapeutic Potential Rob Perry and Ron Fedechko 21 Glass Containers for Parenteral Products Robert Swift, Robert Schaut, Carol Rea Flynn, and Roger Asselta 22 Pharmaceutical Dosage Forms: Parenteral Medications, 4th Edition Elastomeric Closures for Parenterals Renaud Janssen 23 Plastic Packaging for Parenteral Drug Delivery Lloyd Waxman, Frances L DeGrazio, and Vinod D Vilivalam 24 Parenteral Product Container-Closure Integrity Testing Justine Young and Brandon Zurawlow 25 The Management of Extractables and Leachables in Pharmaceutical Products Edward J Smith and Diane M Paskiet 26 Aseptic Manufacturing Facility Design Mark Caldwell, Robert Helt, Beth Holden, Francesca McBride, and Kevin Schreier 27 Personnel and Their Impact on Clean room Operations Jeanne Moldenhauer 28 Preventing Loss of Environmental Control in an Aseptic Processing Facility Rick Friedman 29 Water Systems for Parenteral Facilities Joseph Manfredi 30 Industrial Sterilization Technologies: Principles and Overview Anne F Booth 31 Steam Sterilization James Agalloco 32 Gas, Vapor, and Liquid Phase Sterilization James Agalloco 33 Dry-Heat Depyrogenation and Sterilization Deborah Havlik 34 Radiation Sterilization Barry P Fairand, Dusan Razem, and Karl Hemmerich 35 Filters and Filtration Maik W Jornitz 36 Science of Scale for Freeze Drying Serguei Tchessalov, Sumit Luthra, T N Thompson, and Lisa Graham 37 Quality by Design and Control Strategies for Parenteral Dosage Forms Vinay Radhakrishnan, Amit Banerjee, and Mansoor A Khan 38 Risk Assessment and Mitigation in Aseptic Processing James Agalloco and James Akers 39 Sterile Drug Product Process Validation Walter Manger 40 Visual Inspection Maria R Toler and Sandeep Nema 41 Cleaning Validation--Lifecycle Approach Paul L Pluta 42 Freeze-Drying: Principles and Practice Steven L Nail and Larry A Gatlin 43 Spray Drying of Biotherapeutic Compounds Alex Langford and Satoshi Ohtake 44 Freezing of Proteins and Cells Satish K Singh 45 Parenteral Product Specifications and Stability Michael Bergren and Nanda Subbarao 46 Particulate Matter: Subvisible D Scott Aldrich 47 Endotoxin Testing Michael E Dawson 48 The Compendial Sterility Tests Robert F Guardino and Scott VW Sutton 49 Regulatory Considerations for the Manufacture and Quality Controls for Sterile Products Ramani R Raghavan 50 Future of Parenteral Manufacturing James Agalloco, James Akers, and Russell Madsen Index