Uvod u validaciju metoda analize lijekova

Professional paper - Professional paper

• Author: Marica Medić-Šarić
• Author: Ivona Jasprica
• Author: Željko Debeljak
• Author's institution: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of medicinal chemistry)
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract (english)

Validation of analytical procedures is an integral part of the drug registration process
in the EU, Japan and the USA. Using specific laboratory tests, the validation process assesses that the performance characteristics of the investigated analytical method are suitable for the intended purpose.
The objective of the analytical procedure should be clearly understood since this will
determine the validation parameters that need to be evaluated. Typical validation parameters to be considered are accuracy, precision (repeatability, intermediate precision),
specificity, detection limit, quantification limit, linearity, range and robustness. On a
case by case basis, some validation characteristics should be included or excluded.

• Keywords (croatian): analitičke metode; validacija analitičkih metoda; analiza lijekova
• Language: croatian
• Publication type: Professional paper - Professional paper
• Publication status: Published
• Peer review: Peer review - domestic
• Publication version: Published version
• Journal title: Farmaceutski glasnik
• Numbering: vol. 62, no. 1, pp. 1-7
• p-ISSN: 0014-8202
• URN:NBN: urn:nbn:hr:163:550517
• Publication: 2006
• Type of resource: Text
• Access conditions: Open access
• Created on: 2021-01-07 13:50:33