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Pharmaceutical Dosage Forms: Parenteral Medications, Third Edition, Three Volume Set

Description: This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume one presents: - A historical perspective of injectable drug therapy, common routes of administration, and biopharmaceutics of NCEs and NBEs. - An in-depth discussion on the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. - A presentation of parenteral primary packaging options - glass and plastic containers, as well as elastomeric closures. - A definitive chapter on container-closure integrity. - New chapters on solubility and solubilization, formulation of depot delivery systems and biophysical/biochemical characterization of proteins. Volume two presents: - Chapters on aseptic facility design, environmental monitoring, and cleanroom operations. - A comprehensive chapter on pharmaceutical water systems. - A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. - A detailed chapter on processing of parenteral drug products (SVPs and LVPs). - Presentations on widely used sterilization technologies ­ steam, gas / chemical, radiation, filtration and dry heat. - An in-depth chapter on lyophilization. Volume three presents: - An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. - Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing. - Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems. - New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.

Contents:

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

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