Endotoxins: Pyrogens, LAL Testing and Depyrogenation
Kevin L. Williams
Taylor & Francis, Feb 23, 2007 - Medical - 440 pages
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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Endotoxin Relevance and Control Overview
J Fever and the Host Response
4 Endotoxin Structure Function and Activity
13 other sections not shown
3-glucan acid antibiotic arthropod aseptic associated Bacterial Endotoxin Test binding Biol biological activity blood cells cellular chromogenic Clin clinical clotting coagulation coli components contain cytokine depyrogenation detection dilution disease dose drug product edited effects end product endo endotoxic endotoxin endotoxin concentration endotoxin limit enzyme EU/mg EU/mL excipients factor fever gel-clot gene glucans gram-negative gram-negative bacteria gram-positive Guideline horseshoe crab human Infect Immun kinetic laboratory LAL assay LAL reagent LAL test method levels Limulus amebocyte lysate lipid lipopolysaccharide lipoteichoic acid macrophages manufacturing process medical devices membrane mg/mL microbial Microbiol molecular molecules monocytes nonendotoxin organisms parenteral parenteral drugs parenteral manufacturing pathogens peptidoglycan Pharm pharmaceutical polysaccharide potency protein rabbit pyrogen test reaction receptor release requirements risk assessment sample sensitivity sepsis septic shock soluble solutions specific spike standard curve standard endotoxin sterile structure superantigens Technol toxin validation variability