Endotoxins : Pyrogens, LAL Testing and Depyrogenation

ISBN-13: 9780849393723 / Angielski / Twarda / 2007 / 419 str.

Kevin L. Williams

Opis

This source expertly examines the discovery, control, and application of endotoxin form a parenteral manufacturing perspective, including discussioins of assay development, automation, depyrogenation, and the regulation of endotoxin testing by amebocyte lysate(LAL) methods. Completely revised and expanded, this source contains the knowledge necessary to apply endotoxin technologies in the increasingly complex pharmaceutical environment, and offers neew ans state-of-the-art sections on medical devices, regulation standards, validation procedures, and automated system dvelopments.

Recenzje

”This new volume of Drugs and the Pharmaceutical Sciences” is again a very well-written book, which provides comprehensive information in an  explicable and user friendly manner”
European Journal of Pharmaceutics and Biopharmaceutics
“…well illustrated to support important concepts.  This book should be a familiar reference for anyone seriously interested in endotoxin research or testing.”
--LAL Times (for previous edition)
“…an excellent fifteen-chapter text…this well written, in-depth book will become a standard reference used by those working in this challenging, rapidly changing field.”
--Pharmaceutical Research (for previous edition)

Spis treści

Background.  Historical and Emerging Themes in Parenteral Manufacturing Contamination Control.  Endotoxin Relevance and Control Overview.  Fever and the Host Response.  Endotoxin Structure, Function and Activity.  Descent of Limulus.  Microbial Biodiversity and LPS Heterogeneity.  Nonendotoxin Microbial Pyrogens: Lesser Endotoxins, Superantigens and Adventitious Agents.  Parenteral Drug Testing.  Risk Assessment in Parenteral Manufacturing.  Endotoxin as a Standard.  LAL Discovery, Mechanism and Application.  LAL Assay Development, Validation and Regulation.  The Pyrogen Test.  Pyrogenicity Case Studies.  Developing Specifications for API, Excipients and Sterile Pharmacy Compounds.  Depyrogenation Validation, Pyroburden, and Endotoxin Removal.  Automation, PAT and Prospective Tests.  Medical Devices.  LAL Testing of Medical Devices.  Clinical.  Receptors, Mediators, and Mechanisms Involved in Bacterial Sepsis and Septic Shock

O autorze

Kevin L. Williams