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Professional paper - Professional paper
Uvod u validaciju metoda analize lijekova
Farmaceutski glasnik, 62 (2006), 1; 1-7. urn:nbn:hr:163:550517
Medić-Šarić, Marica; Jasprica, Ivona; Debeljak, Željko

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Medić Šarić, M., Jasprica, I. & Debeljak, Ž. (2006). Uvod u validaciju metoda analize lijekova. Farmaceutski glasnik, 62. (1), 1-7. Retrieved from https://urn.nsk.hr/urn:nbn:hr:163:550517

Medić Šarić, Marica, et al. "Uvod u validaciju metoda analize lijekova." Farmaceutski glasnik, vol. 62, no. 1, 2006, pp. 1-7. https://urn.nsk.hr/urn:nbn:hr:163:550517

Medić Šarić, Marica, Ivona Jasprica and Željko Debeljak. "Uvod u validaciju metoda analize lijekova." Farmaceutski glasnik 62, no. 1 (2006): 1-7. https://urn.nsk.hr/urn:nbn:hr:163:550517

Medić Šarić, M., Jasprica, I. and Debeljak, Ž. (2006) 'Uvod u validaciju metoda analize lijekova', Farmaceutski glasnik, 62(1), pp. 1-7. Available at: https://urn.nsk.hr/urn:nbn:hr:163:550517 (Accessed 22 November 2024)

Medić Šarić M, Jasprica I, Debeljak Ž. Uvod u validaciju metoda analize lijekova. Farmaceutski glasnik [Internet]. 2006 [cited 2024 November 22];62(1):1-7. Available at: https://urn.nsk.hr/urn:nbn:hr:163:550517

M. Medić Šarić, I. Jasprica and Ž. Debeljak, "Uvod u validaciju metoda analize lijekova", Farmaceutski glasnik, vol. 62, no. 1, pp. 1-7, 2006. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:163:550517. [Accessed: 22 November 2024]

Metadata
Title (croatian)Uvod u validaciju metoda analize lijekova
AuthorMarica Medić-Šarić
AuthorIvona Jasprica
AuthorŽeljko Debeljak
Author's institutionUniversity 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)
Languagecroatian
Publication typeProfessional paper - Professional paper
Publication statusPublished
Peer reviewPeer review - domestic
Publication versionPublished version
Journal titleFarmaceutski glasnik
Numberingvol. 62, no. 1, pp. 1-7
p-ISSN0014-8202
URN:NBNurn:nbn:hr:163:550517
Publication2006
Type of resourceText
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2021-01-07 13:50:33