Method transfer, partial validation, and cross validation: recommendations for best practices and harmonization from the global bioanalysis consortium harmonization team.

Autor: Briggs RJ; Eurofins, Abingdon, UK, ray.briggs@merckgroup.com., Nicholson R, Vazvaei F, Busch J, Mabuchi M, Mahesh KS, Brudny-Kloeppel M, Weng N, Galvinas PA, Duchene P, Hu P, Abbott RW
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2014 Nov; Vol. 16 (6), pp. 1143-8. Date of Electronic Publication: 2014 Sep 05.
DOI: 10.1208/s12248-014-9650-3
Abstrakt: This paper presents the recommendations of the Global Bioanalytical Consortium Harmonization Team on method transfer, partial validation, and cross validation. These aspects of bioanalytical method validation, while important, have received little detailed attention in recent years. The team has attempted to define, separate, and describe these related activities, and present practical guidance in how to apply these techniques.
Databáze: MEDLINE