Pharmaceutical dosage forms : parenteral medications. Volume 1, Formulation and packaging

 Content: 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