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Endotoxin testing: the international regulatory landscape

European Pharmaceutical Review

Timely implementation of the reference to USP <86> in the water for injection and purified water monographs is desired to encourage and enable the adoption of these methods for environmental monitoring purposes. Want to learn more about endotoxin testing and validation…? Download our latest report today!

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SMi’s 10th Annual Pharmaceutical Microbiology UK Conference

pharmaphorum

Gain insight the current state of Endotoxin testing, including alternative test methods and strategic approaches to method validation. Download the brochure at: [link]. Explore the best practice in data integrity and the automation of environmental monitoring in the Microbiology Quality Control Lab. Who Should Attend?

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Flow cytometry: advantages in immunotherapy clinical trials

Pharmaceutical Technology

To ensure the quality of FCM assay performance in preclinical and clinical applications, several scientific organizations developed recommendations for FCM instrumentation and method validation. The FDA and/or other regulatory agencies typically request validation reports to evaluate the assay performance for the intended purpose.2,3.