Volume I Parenteral Dosage Forms: Introduction and Historical Perspectives John D. Ludwig Parenteral Drug Administration: Routes of Administration and Devices Himanshu Bhattacharjee and Laura A. Thoma Biopharmaceutics and Immunogenicity of Biotherapeutics Balaji Agoram, Kazuko Sagawa, Ravi M Shanker, and Satish Singh Preformulation Research of Parenteral Medication Murti Vemuri Formulation Development of Small and Large Volume Injections Madhav Kamat and Patrick P. DeLuca Solubility and Solubilization Michael Hageman Formulation of Depot Delivery Systems James J. Cunningham, Marc J. Kirchmeier, and Sachin Mittal Biophysical and Biochemical Characterization of Peptide and Protein Drug Product Tapan K. Das and James A. Carroll Formulation of Protein- and Peptide-based Parenteral Products Gaozhong Zhu and Y. John Wang Development of Ophthalmic Formulations Paramita Bandyopadhyay, Martin J. Coffey, and Mohannad Shawer Glass containers for Parenteral Products Robert Swift Plastic Packaging for Parenteral Drug Delivery Vinod D. Vilivalam and Fran DeGrazio Elastomeric Closures for Parenterals Renaud Janssen Parenteral Product Container-Closure Integrity Testing Dana Morton Guazzo 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 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 Assurance Michael 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