Toward decision-based acceptance criteria for Bioanalytical Method Validation: a proposal for discussion from the European Bioanalysis Forum

Bioanalysis. 2018 Aug 1;10(16):1255-1259. doi: 10.4155/bio-2018-0131. Epub 2018 Aug 21.

Authors

Philip Timmerman¹, Michaela Golob², Joanne Goodman³, Magnus Knutsson⁴, Robert Nelson⁵, Marianne Scheel Fjording⁶, Steve White⁷

Affiliations

¹ European Bioanalysis Forum, Havenlaan 86c b204, 1000 Brussels, Belgium.
² Nuvisan, Grafing, Germany.
³ MedImmune, Cambridge, UK.
⁴ Ferring, Copenhagen, Denmark.
⁵ Novimmune, Geneva, Switzerland.
⁶ Novo Nordisk, Måløv, Denmark.
⁷ GlaxoSmithKline, Ware, UK.

PMID: 30130129
DOI: 10.4155/bio-2018-0131

No abstract available

MeSH terms

Chemistry Techniques, Analytical*
Decision Making*
Europe
Reproducibility of Results