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For: 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: 37] [Article Influence: 6.4] [Reference Citation Analysis]
Number Citing Articles
1 Jordan G, Moheysen-Zadeh M, Dahl U, Staack RF. Novel isoelectric target depletion (ITaD) protocol reduces the need for specific reagents for immunogenicity testing. Bioanalysis 2022. [PMID: 35642540 DOI: 10.4155/bio-2022-0060] [Reference Citation Analysis]
2 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] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
3 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]
4 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]
5 Chen J, Kendra K, Shank S, Rafique A, Ehrlich G, Lin KJ, DeStefano L, Andisik MD, Partridge MA, Torri A, Sumner G. Assay pH and critical reagent optimization in measuring concentrations of a monoclonal antibody and its target. Bioanalysis 2022. [PMID: 35297286 DOI: 10.4155/bio-2021-0276] [Reference Citation Analysis]
6 Kittinger C, Delmar J, Hewitt L, Holcomb R, Jones C, Jones H, Kubiak R, Lee N, McClenny LC, Mody N, O'Connor E. Critical reagents for ligand-binding assays: process development methodologies to enable high-quality reagents. Bioanalysis 2022. [PMID: 35019733 DOI: 10.4155/bio-2021-0217] [Reference Citation Analysis]
7 Patterson M, Beausang LA, Rup B, Bowsher RR, Krug K, Melhem M, Lu S. A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody. AAPS Open 2021;7. [DOI: 10.1186/s41120-021-00045-y] [Reference Citation Analysis]
8 Hassanein M, Wang Y, Yin D, Baltrukonis D. Towards a more patient-centric assessment of immunogenicity for low-risk biologics in immuno-oncology clinical trials. Bioanalysis 2021;13:1309-12. [PMID: 34470480 DOI: 10.4155/bio-2021-0169] [Reference Citation Analysis]
9 Jordan G, Staack RF. An Alternative Data Transformation Approach for ADA Cut Point Determination: Why Not Use a Weibull Transformation? AAPS J 2021;23:97. [PMID: 34389881 DOI: 10.1208/s12248-021-00625-6] [Cited by in F6Publishing: 1] [Reference Citation Analysis]
10 Lu S, Bowsher RR, Clancy A, Rosen A, Zhang M, Yang Y, Koeck K, Gao M, Potocka E, Guo W, Jen KY, Im E, Milton A. An Integrated Analysis of Dostarlimab Immunogenicity. AAPS J 2021;23:96. [PMID: 34324079 DOI: 10.1208/s12248-021-00624-7] [Cited by in F6Publishing: 3] [Reference Citation Analysis]
11 Walters RR, Boucher JF, De Toni F. Pharmacokinetics and Immunogenicity of Frunevetmab in Osteoarthritic Cats Following Intravenous and Subcutaneous Administration. Front Vet Sci 2021;8:687448. [PMID: 34179175 DOI: 10.3389/fvets.2021.687448] [Reference Citation Analysis]
12 Hoyt CC. Multiplex Immunofluorescence and Multispectral Imaging: Forming the Basis of a Clinical Test Platform for Immuno-Oncology. Front Mol Biosci 2021;8:674747. [PMID: 34150850 DOI: 10.3389/fmolb.2021.674747] [Cited by in F6Publishing: 4] [Reference Citation Analysis]
13 Haulenbeek J, Beaver CJ. The impact of ligand binding based assays critical reagent characterization and storage. Bioanalysis 2021;13:797-805. [PMID: 34002637 DOI: 10.4155/bio-2020-0288] [Cited by in F6Publishing: 1] [Reference Citation Analysis]
14 Liu Y, Robinson R, Ung T, Spais C, Schreiber J, Lyons J, Husten J, Hallak H, Angeles T. Development of a Meso Scale Discovery ligand-binding assay for measurement of free (drug-unbound) target in nonhuman primate serum. Bioanalysis 2021;13:575-85. [PMID: 33749335 DOI: 10.4155/bio-2020-0307] [Cited by in F6Publishing: 1] [Reference Citation Analysis]
15 Rist PM, Kupelian V, Petrillo M, Sohn J, Farwell W, Sesso HD. 14-Year Changes in Plasma Neurofilament Levels Among Men: A Pilot Study. J Neuromuscul Dis 2021;8:621-4. [PMID: 33612493 DOI: 10.3233/JND-200623] [Reference Citation Analysis]
16 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: 10] [Article Influence: 1.0] [Reference Citation Analysis]
17 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: 9] [Article Influence: 2.0] [Reference Citation Analysis]
18 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: 15] [Article Influence: 3.0] [Reference Citation Analysis]
19 Hassanein M, Partridge MA, Shao W, Torri A. Assessment of clinically relevant immunogenicity for mAbs; are we over reporting ADA? Bioanalysis 2020;12:1325-36. [PMID: 32946271 DOI: 10.4155/bio-2020-0174] [Cited by in Crossref: 2] [Cited by in F6Publishing: 2] [Article Influence: 1.0] [Reference Citation Analysis]
20 Jordan G, Staack RF. Toward comparability of anti-drug antibody assays: is the amount of anti-drug antibody–reagent complexes at cut-point (CP-ARC) the missing piece? Bioanalysis 2020;12:1021-31. [DOI: 10.4155/bio-2020-0143] [Cited by in Crossref: 1] [Cited by in F6Publishing: 5] [Article Influence: 0.5] [Reference Citation Analysis]
21 Bano N, McKelvey T, Spear N, Yang TY, Shankar G, Schantz A. Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products. Bioanalysis 2019;11:2283-96. [PMID: 31845602 DOI: 10.4155/bio-2019-0241] [Cited by in Crossref: 2] [Cited by in F6Publishing: 3] [Article Influence: 1.0] [Reference Citation Analysis]
22 Wadhwa M, Thorpe R. Harmonization and standardization of immunogenicity assessment of biotherapeutic products. Bioanalysis 2019;11:1593-604. [PMID: 31697206 DOI: 10.4155/bio-2019-0202] [Cited by in Crossref: 6] [Cited by in F6Publishing: 6] [Article Influence: 3.0] [Reference Citation Analysis]
23 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: 47] [Article Influence: 9.3] [Reference Citation Analysis]
24 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: 14] [Article Influence: 3.7] [Reference Citation Analysis]
25 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: 20] [Article Influence: 4.7] [Reference Citation Analysis]
26 Kurki P. Compatibility of immunogenicity guidance by the EMA and the US FDA. Bioanalysis 2019;11:1619-29. [DOI: 10.4155/bio-2018-0243] [Cited by in Crossref: 5] [Cited by in F6Publishing: 6] [Article Influence: 1.7] [Reference Citation Analysis]
27 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: 8] [Article Influence: 2.0] [Reference Citation Analysis]
28 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: 10] [Article Influence: 3.0] [Reference Citation Analysis]
29 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: 7] [Article Influence: 2.0] [Reference Citation Analysis]
30 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]
31 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: 3] [Article Influence: 0.5] [Reference Citation Analysis]
32 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: 30] [Article Influence: 6.5] [Reference Citation Analysis]
33 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: 23] [Article Influence: 3.8] [Reference Citation Analysis]
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