European Bioanalysis Forum and the way forward towards harmonized regulations

“The guidance should … clearly distinguish which parameters must be assessed either for chromatography-based methods or ligand-binding-based methods…” It is a great opportunity for the bioanalytical community around the world to exchange views and positions on bioanalysis in a journal that is specifically dedicated to that field in order to foster mutual agreement and to further develop our area of expertise. Everybody in drug R&D recognizes nowadays that a thorough understanding of the circumstances under which experiments and studies, from drug candidate selection to late-phase clinical development, are conducted and samples analyzed is of extremely high importance for the correct...

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