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PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, Wiethoff CM, Xia CQ, Zhu X, Jawa V, Chemuturi N. Kavita U, et al. Among authors: braun iv, braun m. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Yang TY, Braun M, Lembke W, McBlane F, Kamerud J, DeWall S, Tarcsa E, Fang X, Hofer L, Kavita U, Upreti VV, Gupta S, Loo L, Johnson AJ, Chandode RK, Stubenrauch KG, Vinzing M, Xia CQ, Jawa V. Yang TY, et al. Among authors: braun m. Mol Ther Methods Clin Dev. 2022 Aug 2;26:471-494. doi: 10.1016/j.omtm.2022.07.018. eCollection 2022 Sep 8. Mol Ther Methods Clin Dev. 2022. PMID: 36092368 Free PMC article. Review.
Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Braun M, Lange C, Schatz P, Long B, Stanta J, Gorovits B, Tarcsa E, Jawa V, Yang TY, Lembke W, Miller N, McBlane F, Christodoulou L, Yuill D, Milton M. Braun M, et al. Mol Ther Methods Clin Dev. 2024 Feb 20;32(1):101217. doi: 10.1016/j.omtm.2024.101217. eCollection 2024 Mar 14. Mol Ther Methods Clin Dev. 2024. PMID: 38496304 Free PMC article. Review.
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: braun m. 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: braun m. Bioanalysis. 2021 Dec;13(23):1723-1729. doi: 10.4155/bio-2021-0218. Epub 2021 Oct 28. Bioanalysis. 2021. PMID: 34708666 Free article.
Preclinical Efficacy of the Auristatin-Based Antibody-Drug Conjugate BAY 1187982 for the Treatment of FGFR2-Positive Solid Tumors.
Sommer A, Kopitz C, Schatz CA, Nising CF, Mahlert C, Lerchen HG, Stelte-Ludwig B, Hammer S, Greven S, Schuhmacher J, Braun M, Zierz R, Wittemer-Rump S, Harrenga A, Dittmer F, Reetz F, Apeler H, Jautelat R, Huynh H, Ziegelbauer K, Kreft B. Sommer A, et al. Among authors: braun m. Cancer Res. 2016 Nov 1;76(21):6331-6339. doi: 10.1158/0008-5472.CAN-16-0180. Epub 2016 Aug 19. Cancer Res. 2016. PMID: 27543601
2,425 results