Naslov
A practical validation approach for virus titer testing of avian infectious bursal disease live vaccine according to current regulatory guidelines

Autori
Weber Sušanj, Mirta ; Košiček, Miljenko ; Kosor Krnić, Ela ; Ballarin-Perharić, Alenka ; Terzić, Svjetlana

Izvornik
Biologicals (1045-1056) 40 (2012), 1; 41-48

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
virus titer; bioassay validation; infectious bursal disease vaccine; non-parametric statistics

Sažetak
The method for virus titer determination of avian infectious bursal disease (IBD) live vaccine, developed long before regulatory validation guidelines is a cell culture based biological assay intended for use in vaccine release testing. The aim of our study was to perform a validation, based on fit-for purpose principle, of an old 50% tissue culture infectious dose (TCID50) method according to Guidelines of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This paper addresses challenges and discusses some key aspects that should be considered when validating biological methods. A different statistical approach and non-parametric statistics was introduced in validation protocol in order to derive useful information from experimental data. This approach is applicable for a wide range of methods. In conclusion, the previous virus titration method had showed to be precise, accurate, linear, robust and in accordance with current regulatory standards, which indicates that there is no need for additional re-development or upgrades of the method for its suitability for intended use.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti, Veterinarska medicina, Farmacija

POVEZANOST RADA