Edwin van den Heuvel (Eindhoven University of Technology)

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Testing non-inferiority for accuracy of quantitative microbiological methods

21 June 2022 | By Edwin van den Heuvel (Eindhoven University of Technology), Kathrin Möllenhoff (Heinrich-Heine-University), Maliheh Heidari (Eindhoven University of Technology), Pieta IJzerman-Boon (Center for Mathematical Sciences)

Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.

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Primary validation of the growth direct bioburden system and media

30 October 2020 | By Abu Manju (Eindhoven University of Technology), David Jones (Rapid Micro Biosystems), Edwin van den Heuvel (Eindhoven University of Technology), Jaime Brosseau (Rapid Micro Biosystems), Niloufar Parsaei (Rapid Micro Biosystems)

This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.