Validation of Test Result Equivalence for Alternative BET assays... - Seguridad Mania.com - España y América Latina
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Martes 2 de Jul, 2024
Full title: Validation of Test Result Equivalence for Alternative BET assays, Including Recombinant Methods Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, John Duguid, Executive Director, Research & Development at Vericel Corporation, Steven Walfish, Principal Consultant at Statistical Outsourcing Services and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza Both FDA’s 2012 Guidance for Industry and USP <1223> specifically use the term, “equivalence” as a requirement for validating an alternative test. Traditional methods, such as the Limulus amebocyte lysate (LAL) assay, are widely accepted and have a proven record of assuring parenteral drug and device safety, but they have limitations, including reagent variability and sustainability concerns. As a result, new methods using a number of innovative platforms, including recombinant technology (rFC and rCR), have emerged. The concept of test result equivalence bridges the gap between old and new technologies, offering cost-effective, environmentally friendly, and reproducible means of endotoxins detection, advancing the industry's ability to ensure continued product quality and patient safety. This webinar will explore the concepts of equivalence, comparability, and statistical methods used to evaluate them.
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La Autoridad Portuaria de la Bahía de Algeciras (APBA) ha instalado cámaras térmicas en las zonas de mayor tránsito de pasajeros del puerto para controlar la temperatura corporal de los pasajeros sin necesidad de pararles. ... Leer más ►
Tags: Casos, Transporte, Video analítica
Publicado el 2-Jul-2020 • 14.23hs
Publicado el 25-Ene-2017 • 19.27hs
Publicado el 20-Ene-2017 • 13.11hs
Publicamos grabación de webinar que tuvo lugar el pasado 28/03/2019 por el CIO del Grupo de Medios de Comunicación español Vocento Jorge Oteo en el que explica su visión de la Ciberseguridad hoy. ... Leer más ►
Tags: Teoría, Medios de Comunicación, Ciberseguridad, Webinars grabados
Publicado el 29-Mar-2019 • 10.12hs
Publicado el 20-Jun-2018 • 11.21hs
Publicado el 31-May-2018 • 10.21hs
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Tags: Producto, Todos, Ciberterrorismo
Publicado el 23-Jun-2020 • 16.05hs
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Publicado el 20-Jun-2014 • 17.17hs
Publicado el 31-May-2011 • 05.13hs
Publicado el 25-Set-2008 • 17.54hs
Publicado el 1-Set-2016 • 16.11hs
Publicado el 31-Ago-2016 • 18.53hs
Publicado el 19-Ene-2017 • 15.47hs
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Publicado el 7-Oct-2016 • 04.54hs
Publicado el 4-Dic-2014 • 12.50hs
Publicado el 22-Jul-2014 • 09.54hs
Publicado el 26-Set-2019 • 10.36hs
Publicado el 29-Mar-2019 • 10.12hs
Publicado el 23-Jun-2020 • 16.05hs
Publicado el 15-Mar-2019 • 10.41hs
Publicado el 4-Feb-2016 • 11.56hs
Publicado el 21-Jun-2012 • 22.28hs
Publicado el 13-Jul-2012 • 07.12hs
Publicado el 17-Ene-2012 • 10.22hs
Publicado el 25-Ene-2017 • 19.27hs
Publicado el 18-Set-2013 • 17.44hs
Publicado el 17-May-2018 • 10.47hs
Publicado el 28-Dic-2015 • 12.39hs
Publicado el 5-Feb-2016 • 13.01hs
Publicado el 2-Jul-2020 • 14.23hs
Publicado el 25-May-2016 • 13.01hs