| Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays CT Viswanathan, S Bansal, B Booth, AJ DeStefano, MJ Rose, J Sailstad, ... Pharmaceutical research 24, 1962-1973, 2007 | 1224* | 2007 |
| Fit-for-purpose method development and validation for successful biomarker measurement JW Lee, V Devanarayan, YC Barrett, R Weiner, J Allinson, S Fountain, ... Pharmaceutical research 23, 312-328, 2006 | 849 | 2006 |
| CTLA4Ig-mediated blockade of T-cell costimulation in patients with psoriasis vulgaris JR Abrams, MG Lebwohl, CA Guzzo, BV Jegasothy, MT Goldfarb, ... The Journal of clinical investigation 103 (9), 1243-1252, 1999 | 786 | 1999 |
| Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules B DeSilva, W Smith, R Weiner, M Kelley, JM Smolec, B Lee, M Khan, ... Pharmaceutical research 20, 1885-1900, 2003 | 635 | 2003 |
| Workshop report and follow-up—AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples—implications of Crystal City recommendations DM Fast, M Kelley, CT Viswanathan, J O’Shaughnessy, SP King, ... The AAPS journal 11, 238-241, 2009 | 212 | 2009 |
| Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report JW Lee, RS Weiner, JM Sailstad, RR Bowsher, DW Knuth, PJ O’Brien, ... Pharmaceutical research 22, 499-511, 2005 | 206 | 2005 |
| Prognostic significance of PD-L1 in patients with non–small cell lung cancer: a large cohort study of surgically resected cases JM Sun, W Zhou, YL Choi, SJ Choi, SE Kim, Z Wang, M Dolled-Filhart, ... Journal of Thoracic Oncology 11 (7), 1003-1011, 2016 | 152 | 2016 |
| Bioanalytical method validation for macromolecules in support of pharmacokinetic studies JM Smolec, B DeSilva, W Smith, R Weiner, M Kelly, B Lee, M Khan, ... Pharmaceutical research 22, 1425-1431, 2005 | 111 | 2005 |
| 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 | 98 | 2015 |
| Workshop on bioanalytical methods validation for macromolecules: summary report KJ Miller, RR Bowsher, A Celniker, J Gibbons Pharmaceutical research 18 (9), 1373, 2001 | 93 | 2001 |
| 2011 White Paper on recent issues in bioanalysis and regulatory findings from audits and inspections F Garofolo, ML Rocci, I Dumont, S Martinez, S Lowes, E Woolf, ... Bioanalysis 3 (18), 2081-2096, 2011 | 91 | 2011 |
| 2012 White Paper on recent issues in bioanalysis and alignment of multiple guidelines B DeSilva, F Garofolo, M Rocci, S Martinez, I Dumont, F Landry, C Dicaire, ... Bioanalysis 4 (18), 2213-2226, 2012 | 88 | 2012 |
| Navigating the rapids: the development of regulated next-generation sequencing-based clinical trial assays and companion diagnostics S Pant, R Weiner, MJ Marton Frontiers in oncology 4, 78, 2014 | 86 | 2014 |
| Development of a prototype immunohistochemistry assay to measure programmed death ligand-1 expression in tumor tissue M Dolled-Filhart, D Locke, T Murphy, F Lynch, JH Yearley, D Frisman, ... Archives of pathology & laboratory medicine 140 (11), 1259-1266, 2016 | 79 | 2016 |
| Attribution of the discrepancy between ELISA and LC-MS/MS assay results of a PEGylated scaffold protein in post-dose monkey plasma samples due to the presence of anti-drug … SJ Wang, ST Wu, J Gokemeijer, A Fura, M Krishna, P Morin, G Chen, ... Analytical and bioanalytical chemistry 402, 1229-1239, 2012 | 63 | 2012 |
| Electrochemiluminescence in bioanalysis PW Rhyne, OT Wong, YJ Zhang, RS Weiner Bioanalysis 1 (5), 919-935, 2009 | 44 | 2009 |
| A candidate plasma protein classifier to identify Alzheimer's disease X Zhao, S Lejnine, J Spond, C Zhang, TC Ramaraj, DJ Holder, H Dai, ... Journal of Alzheimer's Disease 43 (2), 549-563, 2015 | 42 | 2015 |
| Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop JPF Bai, R Bell, SA Buckman, GJ Burckart, HG Eichler, KC Fang, ... The AAPS Journal 13, 274-283, 2011 | 39 | 2011 |
| Pharmacokinetics and pharmacodynamics of CTLA4Ig (BMS‐188667), a novel immunosuppressive agent, in monkeys following multiple doses NR Srinivas, RS Weiner, G Warner, WC Shyu, T Davidson, CG Fadrowski, ... Journal of pharmaceutical sciences 85 (1), 1-4, 1996 | 34 | 1996 |
| Assessment of dose proportionality, absolute bioavailability, and immunogenicity response of CTLA4Ig (BMS-188667), a novel immunosuppressive agent, following subcutaneous and … NR Srinivas, WC Shyu, RS Weiner, G Warner, C Comereski, LK Tay, ... Pharmaceutical research 14, 911-916, 1997 | 33 | 1997 |
