Endotoxins

Pyrogens, LAL Testing and Depyrogenation

Buch | Hardcover

440 Seiten

2007 | 3rd edition
Crc Press Inc (Verlag)
978-0-8493-9372-3 (ISBN)

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Examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective. This work shows how to apply endotoxin testing in pharmaceutical environment. It also features information on clinical advances, regulation standards, and validation procedures for computerized kinetic tests.

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.

Kevin L. Williams

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

Erscheint lt. Verlag	23.2.2007
Reihe/Serie	Drugs and the Pharmaceutical Sciences
Zusatzinfo	54 Tables, black and white; 35 Halftones, black and white; 85 Illustrations, black and white
Verlagsort	Bosa Roca
Sprache	englisch
Maße	156 x 234 mm
Gewicht	861 g
Themenwelt	Studium ► Querschnittsbereiche ► Infektiologie / Immunologie
ISBN-10	0-8493-9372-8 / 0849393728
ISBN-13	978-0-8493-9372-3 / 9780849393723
Zustand	Neuware