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Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
Goodman J, Cowen S, Devanarayan V, Egging D, Emrich T, Golob M, Kramer D, McNally J, Munday J, Nelson R, Pedras-Vasconcelos JA, Piironen T, Sickert D, Skibeli V, Fjording MS, Timmerman P. Goodman J, et al. Among authors: skibeli v. Bioanalysis. 2018 Feb;10(4):197-204. doi: 10.4155/bio-2017-4971. Epub 2018 Jan 18. Bioanalysis. 2018. PMID: 29345496
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY. Piccoli S, et al. Among authors: skibeli v. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H. Booth B, et al. Among authors: skibeli v. Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9. Bioanalysis. 2019. PMID: 31833782
Interchangeability of Biosimilars: A European Perspective.
Kurki P, van Aerts L, Wolff-Holz E, Giezen T, Skibeli V, Weise M. Kurki P, et al. Among authors: skibeli v. BioDrugs. 2017 Apr;31(2):83-91. doi: 10.1007/s40259-017-0210-0. BioDrugs. 2017. PMID: 28120313
The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma.
Ali S, Kjeken R, Niederlaender C, Markey G, Saunders TS, Opsata M, Moltu K, Bremnes B, Grønevik E, Muusse M, Håkonsen GD, Skibeli V, Kalland ME, Wang I, Buajordet I, Urbaniak A, Johnston J, Rantell K, Kerwash E, Schuessler-Lenz M, Salmonson T, Bergh J, Gisselbrecht C, Tzogani K, Papadouli I, Pignatti F. Ali S, et al. Among authors: skibeli v. Oncologist. 2020 Feb;25(2):e321-e327. doi: 10.1634/theoncologist.2019-0233. Epub 2019 Oct 16. Oncologist. 2020. PMID: 32043764 Free PMC article. Review.
The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for human use.
Tzogani K, Skibeli V, Westgaard I, Dalhus M, Thoresen H, Slot KB, Damkier P, Hofland K, Borregaard J, Ersbøll J, Salmonson T, Pieters R, Sylvester R, Mickisch G, Bergh J, Pignatti F. Tzogani K, et al. Among authors: skibeli v. Oncologist. 2015 Feb;20(2):196-201. doi: 10.1634/theoncologist.2014-0177. Epub 2015 Jan 23. Oncologist. 2015. PMID: 25616431 Free PMC article. Review.
[Tigecycline--a new antibiotic].
Skibeli V, Aaløkken I, Lingaas E, Midtvedt T, Solberg CO, Melby KK. Skibeli V, et al. Tidsskr Nor Laegeforen. 2010 Aug 26;130(16):1624-6. doi: 10.4045/tidsskr.09.0722. Tidsskr Nor Laegeforen. 2010. PMID: 20805861 Free article. Norwegian.
15 results