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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: emrich t. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675 Free article.
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: emrich t. Bioanalysis. 2018 Feb;10(4):197-204. doi: 10.4155/bio-2017-4971. Epub 2018 Jan 18. Bioanalysis. 2018. PMID: 29345496 Free article.
Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis.
Laurén A, Braun M, Cazzin C, Colleti K, Cox C, Dietz L, Emrich T, Geddes K, Herr K, Iles T, Rogue A, Verlinden Y, Timmerman P. Laurén A, et al. Among authors: emrich t. Bioanalysis. 2022 Aug;14(16):1085-1093. doi: 10.4155/bio-2022-0170. Epub 2022 Sep 20. Bioanalysis. 2022. PMID: 36125042 Free article.
Applying context of use to quantitative polymerase chain reaction method validation and analysis: a recommendation from the European Bioanalysis Forum.
Laurén A, Braun M, Byrne P, Cazzin C, Colletti K, Cox C, Dietz L, Emrich T, Geddes K, Herr K, Iles T, Rogue A, Verlinden Y, Timmerman P. Laurén A, et al. Among authors: emrich t. Bioanalysis. 2021 Dec;13(23):1723-1729. doi: 10.4155/bio-2021-0218. Epub 2021 Oct 28. Bioanalysis. 2021. PMID: 34708666 Free article.
Comparative assessment of immune complex-mediated hypersensitivity reactions with biotherapeutics in the non-human primate: Critical parameters, safety and lessons for future studies.
Kronenberg S, Husar E, Schubert C, Freichel C, Emrich T, Lechmann M, Giusti AM, Regenass F. Kronenberg S, et al. Among authors: emrich t. Regul Toxicol Pharmacol. 2017 Aug;88:125-137. doi: 10.1016/j.yrtph.2017.06.004. Epub 2017 Jun 15. Regul Toxicol Pharmacol. 2017. PMID: 28624430
157 results