• 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

”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)