Endotoxins: Pyrogens, LAL Testing and Depyrogenation

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Kevin L. Williams
CRC Press, Feb 23, 2007 - Medical - 440 pages
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This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation. Completely revised and expanded, this Third Edition contains the knowledge necessary to apply endotoxin testing in the increasingly complex pharmaceutical environment, featuring sections detailing the latest information regarding clinical advances, regulation standards, and validation procedures for computerized kinetic tests.
 

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This book provides invaluable insight and understanding into pyrogens and bacterial endotoxins. As an industrial microbiologist, this book has proved it value time and again when questions arise about the source and significance of endotoxin issues.

Contents

Chapter 1 Historical and Emerging Themes
1
Chapter 2 Endotoxin Relevance and Control Overview
27
Chapter 3 Fever and the Host Response
47
Chapter 4 Endotoxin Structure Function and Activity
67
Arthropoda and the New Biology
91
from Static to Dynamic Models
111
Lesser Endotoxins and Superantigens
133
Chapter 8 Risk Assessment in Parenteral Manufacture
153
Chapter 11 Development Validation and Regulation
221
Chapter 12 The Pyrogen Test
261
Chapter 13 Pyrogenicity Case Studies
273
Chapter 14 Developing Specifications for Active Pharmaceutical Ingredients Excipients Raw Materials Sterile Pharmacy Compounds and Nutritional ...
285
Chapter 15 Depyrogenation Validation Pyroburden and Endotoxin Removal
301
Chapter 16 Automation Process Analytical Technology and Prospective Testing
329
Chapter 17 Limulus Amebocyte Lysate Testing of Medical Devices
361
Chapter 18 Receptors Mediators and Mechanisms Involved in Bacterial Sepsis and Septic Shock
383

Chapter 9 Endotoxin as a Standard
167
Chapter 10 Mechanism and Application
191

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