Philip Timmerman, Matthew Barfield, Enric Bertran Portabella, Salvatore Calogero, Kyra Cowan, Jörg Faber, Luca Ferrari, Michaela Golob, Jo Goodman, Lee Goodwin, Mark Jean Gnoth, Richard Hughes, Tsvetelina Ivanova, Gregor Jordan, Anna Laurén, Delphine Maux, Stuart McDougall, Petya Milushewa, Robert Nelson, Gwenda Pynaert, Kamil Sklodowski, Rebecca Sleigh, Petra Struwe, Tom Verhaeghe, Robert Wheller, Steve White, Katja Zeiser
The ICH M10 guideline on bioanalytical method validation and sample analysis is being adopted since 2023. However, and inevitably, some paragraphs or requirements remain ambiguous and are open for different interpretations. In support of a harmonized interpretation by the industry and health authorities, the European Bioanalysis Forum organized a workshop on 14 November 2023 in Barcelona, Spain, to discuss unclear and/or ambiguous paragraphs which were identified by the European Bioanalysis Forum community and delegates of the workshop prior to the workshop...
February 5, 2024: Bioanalysis