Pharmaceutical dosage forms Parenteral medications Vol 3 Regulations validation and the futuree 3rd Edition by Sandeep Nema, John Ludwig ISBN 978-1420086539 1420086539

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Product details: 

ISBN 10:  1420086539

ISBN 13: 978-1420086539

Author: Sandeep Nema,  John D. Ludwig

Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration.

Volume 1 (Formulation and Packaging) presents a historical perspective of injectable drug therapy. It discusses common routes of administration and biopharmaceutics of NCEs and NBEs. It examines the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. The book also presents a range of parenteral primary packaging options―including glass and plastic containers and elastomeric closures―and discusses container-closure integrity. This edition includes chapters on solubility and solubilization, formulation of depot delivery systems, and biophysical/biochemical characterization of proteins.

Volume 2 (Facility Design, Sterilization and Processing) explores aseptic facility design, environmental monitoring, and cleanroom operations. It discusses pharmaceutical water systems and quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. The book contains a detailed discussion on the processing of parenteral drug products (SVPs and LVPs) as well as widely used sterilization technologies such as steam, gas/chemical, radiation, filtration, and dry heat. It also examines lyophilization.

Volume 3 (Regulations, Validation and the Future) provides an in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. It explores parenteral administrations devices, injection site pain assessment, parenteral product specifications, and stability testing. It also discusses and the future of parenteral product manufacturing and siRNA delivery systems. The book covers recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), as well as validation of drug product manufacturing process.

Each individual volume is also available separately.

Table of contents: 

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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Tags: Sandeep Nema, John Ludwig, Pharmaceutical dosage, Parenteral medications