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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. Among authors: clements egan a. AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y. AAPS J. 2021. PMID: 34853961 Free PMC article.
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. Among authors: clements egan a. AAPS J. 2019 Apr 16;21(4):55. doi: 10.1208/s12248-019-0328-8. AAPS J. 2019. PMID: 30993501
Pre-existing Antibody: Biotherapeutic Modality-Based Review.
Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L. Gorovits B, et al. Among authors: clements egan a. AAPS J. 2016 Mar;18(2):311-20. doi: 10.1208/s12248-016-9878-1. Epub 2016 Jan 28. AAPS J. 2016. PMID: 26821802 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: clements egan a. 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.