| 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV):(Part 2–Hybrid LBA/LCMS and input from regulatory agencies) A Song, A Lee, F Garofolo, S Kaur, J Duggan, C Evans, J Palandra, ... Bioanalysis 8 (23), 2457-2474, 2016 | 39 | 2016 |
| 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV):(Part 3–LBA, biomarkers and immunogenicity) S Richards, L Amaravadi, R Pillutla, H Birnboeck, A Torri, KJ Cowan, ... Bioanalysis 8 (23), 2475-2496, 2016 | 52 | 2016 |
| 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV)(Part 1–small molecules, peptides and small molecule biomarkers by LCMS) E Yang, J Welink, S Cape, E Woolf, J Sydor, C James, D Goykhman, ... Bioanalysis 8 (22), 2363-2378, 2016 | 42 | 2016 |
| 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 | 54 | 2017 |
| 2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule … J Welink, E Yang, N Hughes, B Rago, E Woolf, J Sydor, L Coppola, ... Bioanalysis 9 (22), 1807-1825, 2017 | 37 | 2017 |
| 2017 White Paper on recent issues in bioanalysis: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and … H Neubert, A Song, A Lee, C Wei, J Duggan, K Xu, E Woolf, C Evans, ... Bioanalysis 9 (23), 1895-1912, 2017 | 32 | 2017 |
| 2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs). H Neubert, A Song, A Lee, C Wei, J Duggan, K Xu, E Woolf, C Evans, ... Bioanalysis 9 (23), 1895-1912, 2017 | 9 | 2017 |
| 2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3–LBA/cell-based assays: immunogenicity … L Stevenson, S Richards, R Pillutla, A Torri, J Kamerud, D Mehta, S Keller, ... Bioanalysis 10 (24), 1973-2001, 2018 | 49 | 2018 |
| 2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2–PK, PD & ADA assays by hybrid LBA/LCMS … H Neubert, T Olah, A Lee, S Fraser, R Dodge, O Laterza, M Szapacs, ... Bioanalysis 10 (23), 1897-1917, 2018 | 39 | 2018 |
| 2018 White Paper on Recent Issues in Bioanalysis: ‘A Global Bioanalytical Community Perspective on Last Decade of Incurred Samples Reanalysis (ISR)’ (Part 1 … J Welink, Y Xu, E Yang, A Wilson, N Henderson, L Luo, S Fraser, U Kavita, ... Bioanalysis 10 (22), 1781-1801, 2018 | 36 | 2018 |
| 2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 – Recommendations on 2018 FDA … B Booth, L Stevenson, R Pillutla, M Buonarati, C Beaver, D Fraier, ... Bioanalysis 11 (23), 2099-2132, 2019 | 25 | 2019 |
| 2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A–Recommendations … S Spitz, Y Zhang, S Fischer, K McGuire, U Sommer, L Amaravadi, ... Bioanalysis 13 (5), 295-361, 2021 | 21 | 2021 |
| 2021 White Paper on recent issues in bioanalysis: ISR for biomarkers, liquid biopsies, spectral cytometry, inhalation/oral & multispecific biotherapeutics, accuracy/LLOQ for … S Hersey, S Keller, J Mathews, L King, A Bandukwala, F Berisha, ... Bioanalysis 14 (10), 627-692, 2022 | 14 | 2022 |
| 2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1 … S Kaur, SC Alley, M Szapacs, A Wilson, E Ciccimaro, D Su, N Henderson, ... Bioanalysis, 2022 | 18 | 2022 |
| 2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices … G Sumner, S Keller, J Huleatt, RF Staack, L Wagner, M Azadeh, ... Bioanalysis 15 (15), 861-903, 2023 | 4 | 2023 |
| 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory … M Szapacs, W Jian, D Spellman, J Cunliffe, E Verburg, S Kaur, J Kellie, ... Bioanalysis 15 (16), 955-1016, 2023 | 5 | 2023 |
| 7th drug hypersensitivity meeting: part one DF Carr, WH Chung, RE Jenkiins, M Chaponda, G Nwikue, ... Clinical and Translational Allergy 6 (S3), 31, 2016 | 4 | 2016 |
| A Combinatorial Haplotype of the UDP-Glucuronosyltransferase 1A1 Gene (#60-#IB) Increases Total Bilirubin Concentrations in Japanese Volunteers M Saeki, Y Saito, K Sai, K Maekawa, N Kaniwa, J Sawada, M Kawamoto, ... Clinical chemistry 53 (2), 356-358, 2007 | 14 | 2007 |
| A detection algorithm for drug‐induced liver injury in medical information databases using the Japanese diagnostic scale and its comparison with the council for international … T Hanatani, K Sai, M Tohkin, K Segawa, M Kimura, K Hori, J Kawakami, ... Pharmacoepidemiology and drug safety 23 (9), 984-988, 2014 | 38 | 2014 |
| A multilaboratory validation study of LC/MS biomarker assays for three lysophosphatidylcholines R Ishikawa, K Saito, T Matsumura, K Arai, S Yamauchi, R Goda, H Tachiki, ... Bioanalysis 13 (20), 1533-1546, 2021 | 3 | 2021 |
