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For: Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity). Bioanalysis 2016;8:2475-96. [DOI: 10.4155/bio-2016-4989] [Cited by in Crossref: 36] [Cited by in F6Publishing: 32] [Article Influence: 6.0] [Reference Citation Analysis]
Number Citing Articles
1 Fandozzi C, Evans C, Wilson A, Su D, Anderson M, Clausen V, Dillen L, Garofolo F, Holliman C, Nickbarg E, Olah T, Ramanathan R, Zhang H, Kaur S, Pillutla R, Yu H, Bateman K, Donato LD, Hengel S, Jian W, Jones B, Kellie J, Lee A, Palandra J, Savoie N, Shipkova P, Spitz S, Su D, Szapacs M, Wang J, Wright K, Zeng J. 2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 - Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis). Bioanalysis 2019;11:2029-48. [PMID: 31808716 DOI: 10.4155/bio-2019-0260] [Cited by in Crossref: 14] [Cited by in F6Publishing: 14] [Article Influence: 4.7] [Reference Citation Analysis]
2 Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H. 2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity). Bioanalysis 2019;11:2099-132. [PMID: 31833782 DOI: 10.4155/bio-2019-0270] [Cited by in Crossref: 11] [Cited by in F6Publishing: 6] [Article Influence: 3.7] [Reference Citation Analysis]
3 Fischer SK. Factors that impact pharmacokinetic measurements of antibody therapeutics: what is your PK assay telling you? Bioanalysis 2017;9:1531-3. [DOI: 10.4155/bio-2017-0173] [Cited by in Crossref: 2] [Cited by in F6Publishing: 1] [Article Influence: 0.4] [Reference Citation Analysis]
4 Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY. 2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62). Bioanalysis 2019;11:2207-44. [PMID: 31820675 DOI: 10.4155/bio-2019-0271] [Cited by in Crossref: 28] [Cited by in F6Publishing: 30] [Article Influence: 9.3] [Reference Citation Analysis]
5 Parr MK, Schmidt AH. Life cycle management of analytical methods. Journal of Pharmaceutical and Biomedical Analysis 2018;147:506-17. [DOI: 10.1016/j.jpba.2017.06.020] [Cited by in Crossref: 32] [Cited by in F6Publishing: 19] [Article Influence: 8.0] [Reference Citation Analysis]
6 Tu J, Bennett P. Parallelism experiments to evaluate matrix effects, selectivity and sensitivity in ligand-binding assay method development: pros and cons. Bioanalysis 2017;9:1107-22. [DOI: 10.4155/bio-2017-0084] [Cited by in Crossref: 22] [Cited by in F6Publishing: 19] [Article Influence: 4.4] [Reference Citation Analysis]
7 Garofolo W, Savoie N. The Decennial Index of the White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’. Bioanalysis 2017;9:1681-704. [DOI: 10.4155/bio-2017-4979] [Cited by in Crossref: 30] [Cited by in F6Publishing: 25] [Article Influence: 6.0] [Reference Citation Analysis]
8 Neubert H, Alley SC, Lee A, Jian W, Buonarati M, Edmison A, Garofolo F, Gorovits B, Haidar S, Mylott B, Nouri P, Qian M, Vinter S, Voelker T, Welink J, Wu J, Yang E, Yu H, Evans C, Summerfield S, Wang J, Bateman K, Boer J, Dean B, Dillen L, Faustino P, Ferrari L, Hughes N, Luo L, Olah T, Post N, Spellman DS, Sydor J, Zhang H, Zhang J, Zhang J, Fandozzi C, Wilson A, Fraier D, Beaver CJ, Dandamudi S, Dasgupta A, Elliott R, Ji A, Li W, McGuinness M, Lima Santos GM, Mirza T, Savoie N, Shakleya D, Sporring S, Stojdl S, Sundman P, Tampal N, Woolf E. 2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos). Bioanalysis 2021;13:203-38. [PMID: 33470871 DOI: 10.4155/bio-2020-0324] [Cited by in Crossref: 3] [Cited by in F6Publishing: 3] [Article Influence: 3.0] [Reference Citation Analysis]
9 Santockyte R, Zeng J, Zheng N. Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC–MS. Bioanalysis 2019;11:785-95. [DOI: 10.4155/bio-2018-0277] [Cited by in Crossref: 9] [Cited by in F6Publishing: 9] [Article Influence: 3.0] [Reference Citation Analysis]
10 Piccoli SP, Garofolo F. Biomarker assay validation. Bioanalysis 2018;10:889-91. [DOI: 10.4155/bio-2018-0127] [Cited by in Crossref: 6] [Cited by in F6Publishing: 4] [Article Influence: 1.5] [Reference Citation Analysis]
11 Keller S, Purushothama S. Biomarker assays: is it time for a standalone regulatory guidance? Bioanalysis 2018;10:1893-5. [DOI: 10.4155/bio-2018-0279] [Cited by in Crossref: 2] [Cited by in F6Publishing: 2] [Article Influence: 0.5] [Reference Citation Analysis]
12 Islam R, Kar S, Ritzén H, Hays A, Tayyem R, Barry C, Keyhani A, Zimmer J, Cruz Caturla M, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Hughes N, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Cape S, Estdale S, Thomas E, Dinan A, Macneill R, Xiao YQ, Garofolo W, Savoie N, Brown M, Rhyne P, Hristopoulos G, Xu A, Goodwin L, Spriggs F, Xu A, Awaiye K, Hayes R, St Charles J, Bouhajib M, Dimarco C, Dimarco L, Savu SR, Bennett P, Kakkanaiah V, Nehls C, Stouffer B, Tabler E, Briscoe C, Karnik S, Dubey I, Kulagina N, Lindsay J, Beaver C, Williard C, Wang H, Feng H, Malone M, Wells E, Fang X, Moussallie M. Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis. Bioanalysis 2019;11:645-53. [DOI: 10.4155/bio-2019-0072] [Cited by in Crossref: 6] [Cited by in F6Publishing: 5] [Article Influence: 2.0] [Reference Citation Analysis]
13 Loo L, Harris S, Milton M, Meena, Lembke W, Berisha F, Bertholet S, Dessy F, Dodge R, Fang X, Fiscella M, Garofolo F, Gorovits B, Gupta S, Jawa V, Ishii-Watabe A, Long B, Lu Y, Mack T, McGuire K, Nolan K, Pan L, Potthoff B, Purushothama S, Smith D, Solstad T, Sonderegger I, Taddeo F, Tangri S, Wagner L, Wu B, Xu Y, Kirshner S, Verthelyi D, Yan H, Maxfield K, Pedras-Vasconcelos J, Abhari MR, Gupta S, Wu Y, Rajadhyaksha M, Andisik M, Baltrukonis D, Cherry E, Cludts I, Gunn G, Millner AH, Jordan G, Kar S, Kubiak R, Lotz GP, Palmer R, Peng K, Poetzl J, Richards S, Savoie N, Staack RF, Stubenrauch K, Wadhwa M, Waxenecker G, Yang TY, Zhang L. 2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization). Bioanalysis 2022. [PMID: 35578991 DOI: 10.4155/bio-2022-0081] [Reference Citation Analysis]
14 Kaur S, Alley SC, Szapacs M, Wilson A, Ciccimaro E, Su D, Henderson N, Chen L, Garofolo F, Hengel S, Jian W, Kellie JF, Lee A, Mehl J, Palandra J, Qiu H, Savoie N, Shakleya D, Staelens L, Sugimoto H, Sumner G, Welink J, Wheller R, Xue YJ, Zeng J, Zhang J, Zhou H, Wang J, Summerfield S, Kavetska O, Dillen L, Ramanathan R, Baratta M, Dasgupta A, Edmison A, Ferrari L, Fischer S, Fraier D, Haidar S, Heermeier K, James C, Ji A, Luo L, Lima Santos GM, Post N, Rosenbaum AI, Sporring S, Surapaneni S, Vinter S, Wan K, Woolf E, Kavetska O, Cho SJ, Kossary E, Prior S, Abhari MR, Soo C, Wang YM, Bandukwala A, Cherry E, Cludts I, Ghosh S, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Maxfield K, Pedras-Vasconcelos J, Saito Y, Smith D, Solstad T, Verthelyi D, Wadhwa M, Wagner L, Waxenecker G, Yan H, Zhang L. 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; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine). Bioanalysis 2022;14:505-80. [PMID: 35578993 DOI: 10.4155/bio-2022-0078] [Reference Citation Analysis]
15 Zhao Y, Gu H, Postelnek J, DeMichele M, Yuan L, Zhang YJ, Zeng J. Fit-for-purpose protein biomarker assay validation strategies using hybrid immunocapture-liquid chromatography-tandem-mass spectrometry platform: Quantitative analysis of total soluble cluster of differentiation 73. Anal Chim Acta 2020;1126:144-53. [PMID: 32736718 DOI: 10.1016/j.aca.2020.06.023] [Cited by in Crossref: 2] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
16 Civoli F, Kasinath A, Cai XY, Wadhwa M, Exley A, Oldfield P, Alvandkouhi S, Schaffar G, Chappell J, Bowsher R, Devanarayan V, Marini J, Rebarchak S, Anderson M, Koppenburg V, Lester T. Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs. AAPS J 2019;22:7. [PMID: 31792633 DOI: 10.1208/s12248-019-0386-y] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 0.3] [Reference Citation Analysis]
17 Neubert H, Olah T, Lee A, Fraser S, Dodge R, Laterza O, Szapacs M, Alley SC, Saad OM, Amur S, Chen L, Cherry E, Cho SJ, Cludts I, Donato LD, Edmison A, Ferrari L, Garofolo F, Haidar S, Hopper S, Hottenstein S, Ishii-Watabe A, Kassim S, Kurki P, Lima Santos GM, Miscoria G, Palandra J, Pedras-Vasconcelos J, Piccoli S, Rogstad S, Saito Y, Savoie N, Sikorski T, Spitz S, Staelens L, Verthelyi D, Vinter S, Wadhwa M, Wang YM, Welink J, Weng N, Whale E, Woolf E, Wu J, Yan H, Yu H, Zhou S. 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 & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity). Bioanalysis 2018;10:1897-917. [PMID: 30488729 DOI: 10.4155/bio-2018-0285] [Cited by in Crossref: 13] [Cited by in F6Publishing: 12] [Article Influence: 3.3] [Reference Citation Analysis]
18 Briscoe C, Hughes N, Hayes R, Islam R, Bennett P, Stouffer B, Cape S, Rhyne P, Beaver C, Charles JS, Kakkanaiah V, Xu A, Caturla MC, Spriggs F, Tayyem R, Barry C, Keyhani A, Zimmer J, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Matassa L, Garofolo W, Savoie N, Hristopoulos G, Xu A, Goodwin L, Awaiye K, Ritzén H, Bouhajib M, Marco CD, Savu SR, Nehls C, Tabler E, Hays A, Karnik S, Brown M, Lowes S, DuBey I, Kulagina N, Lindsay J, Williard C, Wang H, Malone M, Wells E, Fang X, Moussallie M. 12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity. Bioanalysis 2019;11:1129-38. [PMID: 31319683 DOI: 10.4155/bio-2019-0131] [Cited by in Crossref: 6] [Cited by in F6Publishing: 6] [Article Influence: 2.0] [Reference Citation Analysis]
19 Neely RJ. Evolution of fit-for-purpose biomarker validations: an LBA perspective. Bioanalysis 2018;10:905-7. [DOI: 10.4155/bio-2017-0267] [Cited by in Crossref: 2] [Cited by in F6Publishing: 2] [Article Influence: 0.5] [Reference Citation Analysis]
20 Corsaro B, Yang TY, Murphy R, Sonderegger I, Exley A, Bertholet S, Dakappagari N, Dessy F, Garofolo F, Kierstead L, Koch H, Sarikonda G, Savoie N, Siggers R, Solstad T, Lu Y, Milton M, Marshall JC, DelCarpini J, Gorovits B, Gupta S, Jesaitis L, Kamerud J, Kromminga A, Ma A, McNally J, Yan H, Wu B, Verthelyi D, Kirshner S, Pedras-Vasconcelos J, Rajadhyaksha M, Staack RF, Cherry E, Cludts I, Dahlbäck M, Gunn GR, Ishii-Watabe A, Jawa V, Kubiak R, Partridge M, Petrillo M, Pine SO, Poetzl J, Song S, Stebbins C, Wu Y, Zhang L, Kar S, Liang M, Abhari MR, Schweighardt B, Stubenrauch K, Xu Y. 2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays). Bioanalysis 2021;13:415-63. [PMID: 33533276 DOI: 10.4155/bio-2021-0007] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
21 Hersey S, Keller S, Mathews J, King L, Bandukwala A, Berisha F, Birchler M, Bower J, Clausen V, Duarte J, Garofolo F, Hopper S, Kar S, Mabrouk O, Marshall JC, McGuire K, Naughton M, Saito Y, Schuhmann I, Sperinde G, Teixeira P, Vitaliti A, Wang YM, Wnek R, Zhang Y, Spitz S, Decman V, Eck S, Estevam J, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Junker F, Nuti S, Sommer U, Standifer N, Stevens C, Stevens E, Hendricks C, Wadhwa M, Torri A, Ma M, Harris S, Kumar S, Partridge MA, Caiazzo T, Chilewski S, Cludts I, Coble K, Gorovits B, Grimaldi C, Jordan G, Kamerud J, Leary B, Liang M, Lim H, Mayer A, O'Connor E, Palackal N, Poetzl J, Prior S, Abhari MR, Savoie N, Soo C, Ware M, Wu B, Xu Y, Yang TY, Zoghbi J. 2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation). Bioanalysis 2022. [PMID: 35578974 DOI: 10.4155/bio-2022-0080] [Reference Citation Analysis]
22 Arnold ME, Neubert H, Stevenson LF. The breadth of biomarkers and their assays: part 2. Bioanalysis 2016;8:2381-2. [PMID: 27855504 DOI: 10.4155/bio-2016-4984] [Reference Citation Analysis]
23 Wu WS, Zhu L, Patil S, Gokul K, Reilly S, Chan J, Tekumalla P, Vishnudas V, Kiebish MA, Sarangarajan R, Akmaev VR, Kellogg MD, Narain NR. Human CCDC47 sandwich immunoassay development with electrochemiluminescence technology. J Immunol Methods 2018;452:12-9. [PMID: 28974366 DOI: 10.1016/j.jim.2017.09.011] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 0.2] [Reference Citation Analysis]
24 Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R, Stevenson L, Mehta D, Carrasco-triguero M, Neely R, Partridge M, Staack RF, Zhao X, Gorovits B, Kolaitis G, Sumner G, Stubenrauch K, Zou L, Amur S, Beaver C, Berger I, Berisha F, Birnboeck H, Bower J, Cho S(, Cludts I, Cocea L, Donato LD, Fischer S, Fraser S, Garofolo F, Haidar S, Haulenbeek J, Hottenstein C, Hu J, Ishii-watabe A, Islam R, Jani D, Kadavil J, Kamerud J, Kramer D, Kurki P, Macmannis S, Mcnally J, Mullan A, Papadimitriou A, Pedras-vasconcelos J, Ray S, Safavi A, Saito Y, Savoie N, Fjording MS, Scheibner K, Smeraglia J, Song A, Stouffer B, Tampal N, der Strate BV, Verch T, Welink J, Xu Y, Yang T, Yengi L, Zeng J, Zhang Y, Zhang Y, Zoog S. 2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays). Bioanalysis 2017;9:1967-96. [DOI: 10.4155/bio-2017-4974] [Cited by in Crossref: 32] [Cited by in F6Publishing: 27] [Article Influence: 6.4] [Reference Citation Analysis]
25 Yang F, Patton K, Kasprzyk T, Long B, Gupta S, Zoog SJ, Tracy K, Vettermann C. Validation of an IFN-gamma ELISpot assay to measure cellular immune responses against viral antigens in non-human primates. Gene Ther 2021. [PMID: 33432123 DOI: 10.1038/s41434-020-00214-w] [Reference Citation Analysis]
26 Myzithras M, Bigwarfe T, Waltz E, Li H, Ahlberg J, Rybina I, Low S, Kenny CH, Miglietta J, Kroe-barrett R. Optimizing NBE PK/PD assays using the Gyrolab Affinity Software; conveniently within the bioanalyst's existing workflow. Bioanalysis 2018;10:397-406. [DOI: 10.4155/bio-2017-0251] [Cited by in Crossref: 3] [Cited by in F6Publishing: 2] [Article Influence: 0.8] [Reference Citation Analysis]
27 Londhe V, Rajadhyaksha M. Review of Recommendations for Bioanalytical Method Validation: Chromatographic Assays and Ligand Binding Assays. Chromatographia 2019;82:523-35. [DOI: 10.1007/s10337-018-3677-z] [Reference Citation Analysis]
28 Welink J, Xu Y, Yang E, Wilson A, Henderson N, Luo L, Fraser S, Kavita U, Musuku A, James C, Fraier D, Zhang Y, Goykhman D, Summerfield S, Woolf E, Verhaeghe T, Hughes N, Behling A, Brown K, Bulychev A, Buonarati M, Cherry E, Cho SJ, Cludts I, Dillen L, Dodge R, Edmison A, Garofolo F, Green R, Haidar S, Hottenstein C, Ishii-Watabe A, Jang HG, Ji A, Jones B, Kassim S, Ma M, Lima Santos GM, Norris DA, Owen T, Piccoli S, Ramanathan R, Röhl I, Rosenbaum AI, Saito Y, Sangster T, Savoie N, Stebbins C, Sydor J, de Merbel NV, Verthelyi D, Vinter S, Whale E. 2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis). Bioanalysis 2018;10:1781-801. [PMID: 30488725 DOI: 10.4155/bio-2018-0268] [Cited by in Crossref: 15] [Cited by in F6Publishing: 15] [Article Influence: 3.8] [Reference Citation Analysis]
29 Welink J, Yang E, Hughes N, Rago B, Woolf E, Sydor J, Coppola L, Ackermann B, Li W, Alley SC, Arnold M, Berger I, Briscoe C, Buonarati M, Bustard M, Cancilla M, Cho S(, Duggan J, Fraier D, Garofolo F, Green R, Haidar S, Hittle L, Ishii-watabe A, Islam R, Jenkins R, Jones B, Kadavil J, Kassim S, Kavetska O, Blaye OL, Lee A, Liu H, Mehl J, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Surapaneni S, Szapacs M, Tampal N, Verhaeghe T, Vinter S, Whale E. 2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘ Scientific ’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers). Bioanalysis 2017;9:1807-25. [DOI: 10.4155/bio-2017-4975] [Cited by in Crossref: 25] [Cited by in F6Publishing: 22] [Article Influence: 5.0] [Reference Citation Analysis]
30 Muruganandham A, Dumont C, Xing K. Approaching stability challenges for flow cytometry in a regulated bioanalytical environment. Bioanalysis 2019;11:1845-58. [DOI: 10.4155/bio-2019-0183] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 0.3] [Reference Citation Analysis]
31 Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Nuti S, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Exley A, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L. 2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine). Bioanalysis 2021;13:295-361. [PMID: 33511867 DOI: 10.4155/bio-2021-0005] [Cited by in Crossref: 2] [Cited by in F6Publishing: 2] [Article Influence: 2.0] [Reference Citation Analysis]
32 Ryding J, Stahl M, Ullmann M. Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach. Bioanalysis 2017;9:1395-406. [PMID: 28920451 DOI: 10.4155/bio-2017-0111] [Cited by in Crossref: 7] [Cited by in F6Publishing: 4] [Article Influence: 1.4] [Reference Citation Analysis]
33 Laurén A, Goodman J, Blaes J, Cook J, Cowan KJ, Dahlbäck M, Grudzinska-Goebel J, McManus D, Nelson R, Pihl S, Timmerman P. A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum. Bioanalysis 2021;13:537-49. [PMID: 33729007 DOI: 10.4155/bio-2021-0028] [Reference Citation Analysis]
34 Neubert H, Song A, Lee A, Wei C, Duggan J, Xu K, Woolf E, Evans C, Palandra J, Laterza O, Amur S, Berger I, Bustard M, Cancilla M, Chen S, Cho S(, Ciccimaro E, Cludts I, Cocea L, D'arienzo C, Danan-leon L, Donato LD, Garofolo F, Haidar S, Ishii-watabe A, Jiang H, Kadavil J, Kassim S, Kurki P, Blaye OL, Liu K, Mathews R, Lima Santos GM, Niwa M, Pedras-vasconcelos J, Qian M, Rago B, Saad O, Saito Y, Savoie N, Su D, Szapacs M, Tampal N, Vinter S, Wang J, Welink J, Whale E, Wilson A, Xue Y. 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 regulatory agencies’ inputs). Bioanalysis 2017;9:1895-912. [DOI: 10.4155/bio-2017-4973] [Cited by in Crossref: 20] [Cited by in F6Publishing: 19] [Article Influence: 4.0] [Reference Citation Analysis]
35 Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R. 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, biomarkers and PK assays). Bioanalysis 2018;10:1973-2001. [PMID: 30488726 DOI: 10.4155/bio-2018-0287] [Cited by in Crossref: 26] [Cited by in F6Publishing: 24] [Article Influence: 6.5] [Reference Citation Analysis]
36 Ishii-watabe A, Shibata H, Nishimura K, Hosogi J, Aoyama M, Nishimiya K, Saito Y. Immunogenicity of therapeutic protein products: current considerations for anti-drug antibody assay in Japan. Bioanalysis 2018;10:95-105. [DOI: 10.4155/bio-2017-0186] [Cited by in Crossref: 20] [Cited by in F6Publishing: 19] [Article Influence: 5.0] [Reference Citation Analysis]
37 Schreitmüller T, Barton B, Zharkov A, Bakalos G. Comparative immunogenicity assessment of biosimilars. Future Oncol 2019;15:319-29. [PMID: 30278780 DOI: 10.2217/fon-2018-0553] [Cited by in Crossref: 8] [Cited by in F6Publishing: 6] [Article Influence: 2.0] [Reference Citation Analysis]