| Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products G Shankar, V Devanarayan, L Amaravadi, YC Barrett, R Bowsher, ... Journal of pharmaceutical and biomedical analysis 48 (5), 1267-1281, 2008 | 613 | 2008 |
| Antibody-targeted chemotherapy with CMC-544: a CD22-targeted immunoconjugate of calicheamicin for the treatment of B-lymphoid malignancies JF DiJoseph, DC Armellino, ER Boghaert, K Khandke, MM Dougher, ... Blood 103 (5), 1807-1814, 2004 | 466 | 2004 |
| Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products E Koren, HW Smith, E Shores, G Shankar, D Finco-Kent, B Rup, ... Journal of immunological methods 333 (1-2), 1-9, 2008 | 348 | 2008 |
| Bioanalysis of antibody–drug conjugates: american association of pharmaceutical scientists antibody–drug conjugate working group position paper B Gorovits, SC Alley, S Bilic, B Booth, S Kaur, P Oldfield, S Purushothama, ... Bioanalysis 5 (9), 997-1006, 2013 | 161 | 2013 |
| High hydrostatic pressure can reverse aggregation of protein folding intermediates and facilitate acquisition of native structure BM Gorovits, PM Horowitz Biochemistry 37 (17), 6132-6135, 1998 | 137 | 1998 |
| Proposed mechanism of off-target toxicity for antibody–drug conjugates driven by mannose receptor uptake B Gorovits, C Krinos-Fiorotti Cancer Immunology, Immunotherapy 62, 217-223, 2013 | 102 | 2013 |
| Workshop report: Crystal City V—quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance B Booth, ME Arnold, B DeSilva, L Amaravadi, S Dudal, E Fluhler, ... The AAPS Journal 17, 277-288, 2015 | 99 | 2015 |
| Immunoassay methods used in clinical studies for the detection of anti-drug antibodies to adalimumab and infliximab B Gorovits, DJ Baltrukonis, I Bhattacharya, MA Birchler, D Finco, ... Clinical & Experimental Immunology 192 (3), 348-365, 2018 | 84 | 2018 |
| 2019 white paper on recent issues in bioanalysis: FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation (part 3–recommendations … S Piccoli, D Mehta, A Vitaliti, J Allinson, S Amur, S Eck, C Green, ... Bioanalysis 11 (24), 2207-2244, 2019 | 83 | 2019 |
| 2013 White Paper on Recent Issues in Bioanalysis: ‘Hybrid’ – The Best of LBA and LCMS L Stevenson, F Garofolo, B DeSilva, I Dumont, S Martinez, M Rocci, ... Bioanalysis 5 (23), 2903-2918, 2013 | 77 | 2013 |
| A white paper—consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements JM Sailstad, L Amaravadi, A Clements-Egan, B Gorovits, HA Myler, ... The AAPS journal 16 (3), 488-498, 2014 | 75 | 2014 |
| Theoretical considerations and practical approaches to address the effect of anti-drug antibody (ADA) on quantification of biotherapeutics in circulation M Kelley, AB Ahene, B Gorovits, J Kamerud, LE King, T McIntosh, J Yang The AAPS journal 15, 646-658, 2013 | 74 | 2013 |
| Immunogenicity of chimeric antigen receptor T-cell therapeutics B Gorovits, E Koren BioDrugs 33 (3), 275-284, 2019 | 72 | 2019 |
| Pre-existing antibody: biotherapeutic modality-based review B Gorovits, A Clements-Egan, M Birchler, M Liang, H Myler, K Peng, ... The AAPS journal 18, 311-320, 2016 | 72 | 2016 |
| Pharmacokinetics of gemtuzumab ozogamicin as a single‐agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia M Buckwalter, JA Dowell, J Korth‐Bradley, B Gorovits, PR Mayer The Journal of Clinical Pharmacology 44 (8), 873-880, 2004 | 71 | 2004 |
| 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3–LBA, biomarkers and immunogenicity) L Amaravadi, A Song, H Myler, T Thway, S Kirshner, V Devanarayan, ... Bioanalysis 7 (24), 3107-3124, 2015 | 69 | 2015 |
| Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics B Gorovits, E Wakshull, R Pillutla, Y Xu, MS Manning, J Goyal Journal of Immunological Methods 408, 1-12, 2014 | 69 | 2014 |
| Calibration curves in quantitative ligand binding assays: recommendations and best practices for preparation, design, and editing of calibration curves M Azadeh, B Gorovits, J Kamerud, S MacMannis, A Safavi, J Sailstad, ... The AAPS journal 20, 1-16, 2018 | 64 | 2018 |
| 2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3–LBA: immunogenicity, biomarkers and PK … S Gupta, S Richards, L Amaravadi, S Piccoli, B Desilva, R Pillutla, ... Bioanalysis 9 (24), 1967-1996, 2017 | 55 | 2017 |
| Productive and nonproductive intermediates in the folding of denatured rhodanese M Panda, BM Gorovits, PM Horowitz Journal of Biological Chemistry 275 (1), 63-70, 2000 | 53 | 2000 |
Lindsay E KingPfizer在 pfizer.com 的电子邮件经过验证
