title: A practical validation approach for virus titer testing of avian infectious bursal disease live vaccine according to current regulatory guidelines.
abstract: 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 (TCID(50)) 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.
authors: Genera Analytics Ltd., Svetonedjeljska 2, 10 436 Rakov Potok, Croatia. mirta.webersusanj@xnet.hr
authors: Mirta
authors: M
authors: Weber Sušanj
authors: Miljenko
authors: M
authors: Košiček
authors: Ela Kosor
authors: EK
authors: Krnić
authors: Alenka
authors: A
authors: Ballarin-Perharić
authors: Svjetlana
authors: S
authors: Terzić
mesh_terms: D000818:Animals; D001681:Biological Assay / Q000379:methods*; D018175:Birnaviridae Infections / Q000517:prevention & control*; D002478:Cells, Cultured; D002645:Chickens; D005347:Fibroblasts / Q000821:virology*; D017408:Guidelines as Topic; D007243:Infectious bursal disease virus / Q000254:growth & development* / Q000302:isolation & purification; D011201:Poultry Diseases / Q000517:prevention & control* / Q000821:virology; D014613:Vaccines, Attenuated; D014765:Viral Vaccines; D014776:Virus Cultivation / Q000379:methods
chemical_list: D014613:Vaccines, Attenuated; D014765:Viral Vaccines