Analitik yöntem geçerliliğine genel bir bakış: an overview on analytical method validation
Makaleler > Tam Makale · 2005
Yazarlar: Özlem SÖĞÜT ERTAŞ, Aycıl KAYALI
Ankara Universitesi Eczacilik Fakultesi Dergisi, Uluslararası, Scopus, 2005, ss 001-017
DOI: 10.1501/eczfak_0000000014
Özet
Method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. The method’s performance characteristics should be based on the intended use of the method. Parameters of method validations are precision, accuracy, limit of detection, limit of quantification, specificity, linearity and range, sensitivity and robustness. Methods need to be validated or revalidated before their introduction into routine use whenever the conditions change for which the method has been validated, e.g., instrument with different characteristics whenever the method is changed, and the change is outside the original scope of the method procedures