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Page 1
Report on the AAPS Immunogenicity Guidance Forum.
Myler H, Gorovits B, Phillips K, Devanarayan V, Clements-Egan A, Gunn GR, Kirshner S, DeSilva B, Shah VP. Myler H, et al. AAPS J. 2019 Apr 16;21(4):55. doi: 10.1208/s12248-019-0328-8. AAPS J. 2019. PMID: 30993501
Anti-drug Antibody Validation Testing and Reporting Harmonization.
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, Devanaryan V, Gleason C, Goodman J, Manning MS, Purushothama S, Richards S, Shen H, Zoghbi J, Amaravadi L, Barger T, Bowen S, Bowsher RR, Clements-Egan A, Geng D, Goletz TJ, Gunn GR, Hallett W, Hodsdon ME, Janelsins BM, Jawa V, Kamondi S, Kirshner S, Kramer D, Liang M, Lindley K, Liu S, Liu Z, McNally J, Mikulskis A, Nelson R, Ahbari MR, Qu Q, Ruppel J, Snoeck V, Song A, Yan H, Ware M. Myler H, et al. AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y. AAPS J. 2021. PMID: 34853961 Free PMC article.
Neutralizing Antibody Validation Testing and Reporting Harmonization.
Myler H, Pedras-Vasconcelos J, Lester T, Civoli F, Xu W, Wu B, Vainshtein I, Luo L, Hassanein M, Liu S, Ramaswamy SS, Mora J, Pennucci J, McCush F, Lavelle A, Jani D, Ambakhutwala A, Baltrukonis D, Barker B, Carmean R, Chung S, Dai S, DeWall S, Dholakiya SL, Dodge R, Finco D, Yan H, Hays A, Hu Z, Inzano C, Kamen L, Lai CH, Meyer E, Nelson R, Paudel A, Phillips K, Poupart ME, Qu Q, Abhari MR, Ryding J, Sheldon C, Spriggs F, Warrino D, Wu Y, Yang L, Pasas-Farmer S. Myler H, et al. AAPS J. 2023 Jul 8;25(4):69. doi: 10.1208/s12248-023-00830-5. AAPS J. 2023. PMID: 37421491
Quantitative bioanalysis of antibody-conjugated payload in monkey plasma using a hybrid immuno-capture LC-MS/MS approach: Assay development, validation, and a case study.
Liu A, Kozhich A, Passmore D, Gu H, Wong R, Zambito F, Rangan VS, Myler H, Aubry AF, Arnold ME, Wang J. Liu A, et al. Among authors: myler h. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Oct 1;1002:54-62. doi: 10.1016/j.jchromb.2015.08.007. Epub 2015 Aug 12. J Chromatogr B Analyt Technol Biomed Life Sci. 2015. PMID: 26310897
AAPS Workshop Report on ICH M10.
Booth B, Vazvaei F, Fluhler E, Myler H, Woolf E. Booth B, et al. Among authors: myler h. AAPS J. 2019 Dec 10;22(1):10. doi: 10.1208/s12248-019-0398-7. AAPS J. 2019. PMID: 31823177 Free PMC article.
Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development.
Lee JW, Kelley M, King LE, Yang J, Salimi-Moosavi H, Tang MT, Lu JF, Kamerud J, Ahene A, Myler H, Rogers C. Lee JW, et al. Among authors: myler h. AAPS J. 2011 Mar;13(1):99-110. doi: 10.1208/s12248-011-9251-3. Epub 2011 Jan 15. AAPS J. 2011. PMID: 21240643 Free PMC article. Review.
A white paper--consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements.
Sailstad JM, Amaravadi L, Clements-Egan A, Gorovits B, Myler HA, Pillutla RC, Pursuhothama S, Putman M, Rose MK, Sonehara K, Tang L, Wustner JT; Global Bioanalysis Consortium. Sailstad JM, et al. Among authors: myler ha. AAPS J. 2014 May;16(3):488-98. doi: 10.1208/s12248-014-9582-y. Epub 2014 Mar 29. AAPS J. 2014. PMID: 24682765 Free PMC article. Review.
44 results