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Requested Article:
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)
Hendrik Neubert, Stephen C. Alley, Anita Lee, et al.
Bioanalysis (2021) Vol. 13, Iss. 4, pp. 203-238
Closed Access | Times Cited: 26
Hendrik Neubert, Stephen C. Alley, Anita Lee, et al.
Bioanalysis (2021) Vol. 13, Iss. 4, pp. 203-238
Closed Access | Times Cited: 26
Showing 1-25 of 26 citing articles:
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
Johanna Mora, Rachel Palmer, Leslie Wagner, et al.
Bioanalysis (2024) Vol. 16, Iss. 7, pp. 77-119
Closed Access | Times Cited: 6
Johanna Mora, Rachel Palmer, Leslie Wagner, et al.
Bioanalysis (2024) Vol. 16, Iss. 7, pp. 77-119
Closed Access | Times Cited: 6
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)
LiNa Loo, Shannon Harris, Mark Milton, et al.
Bioanalysis (2022) Vol. 14, Iss. 11, pp. 737-793
Closed Access | Times Cited: 25
LiNa Loo, Shannon Harris, Mark Milton, et al.
Bioanalysis (2022) Vol. 14, Iss. 11, pp. 737-793
Closed Access | Times Cited: 25
2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)
Olga Kholmanskikh, Yow‐Ming Wang, Sarah Hersey, et al.
Bioanalysis (2024) Vol. 16, Iss. 8, pp. 179-220
Open Access | Times Cited: 3
Olga Kholmanskikh, Yow‐Ming Wang, Sarah Hersey, et al.
Bioanalysis (2024) Vol. 16, Iss. 8, pp. 179-220
Open Access | Times Cited: 3
Bioanalytical Methods and Strategic Perspectives Addressing the Rising Complexity of Novel Bioconjugates and Delivery Routes for Biotherapeutics
Ruipeng Mu, Jiaqi Yuan, Yue Huang, et al.
BioDrugs (2022) Vol. 36, Iss. 2, pp. 181-196
Open Access | Times Cited: 19
Ruipeng Mu, Jiaqi Yuan, Yue Huang, et al.
BioDrugs (2022) Vol. 36, Iss. 2, pp. 181-196
Open Access | Times Cited: 19
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)
Sarah Hersey, Steve Keller, Joel Mathews, et al.
Bioanalysis (2022) Vol. 14, Iss. 10, pp. 627-692
Closed Access | Times Cited: 18
Sarah Hersey, Steve Keller, Joel Mathews, et al.
Bioanalysis (2022) Vol. 14, Iss. 10, pp. 627-692
Closed Access | Times Cited: 18
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…
Surinder Kaur, Stephen C. Alley, Matt Szapacs, et al.
Bioanalysis (2022) Vol. 14, Iss. 9, pp. 505-580
Closed Access | Times Cited: 18
Surinder Kaur, Stephen C. Alley, Matt Szapacs, et al.
Bioanalysis (2022) Vol. 14, Iss. 9, pp. 505-580
Closed Access | Times Cited: 18
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, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization
Giane Sumner, Steve Keller, James W. Huleatt, et al.
Bioanalysis (2023) Vol. 15, Iss. 15, pp. 861-903
Closed Access | Times Cited: 10
Giane Sumner, Steve Keller, James W. Huleatt, et al.
Bioanalysis (2023) Vol. 15, Iss. 15, pp. 861-903
Closed Access | Times Cited: 10
2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity, Risk-Based Approaches, Ngs, Qpcr, Ddpcr Assays ( Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
Luying Pan, Johanna Mora, Karl Walravens, et al.
Bioanalysis (2023) Vol. 15, Iss. 14, pp. 773-814
Closed Access | Times Cited: 9
Luying Pan, Johanna Mora, Karl Walravens, et al.
Bioanalysis (2023) Vol. 15, Iss. 14, pp. 773-814
Closed Access | Times Cited: 9
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, …
Matt Szapacs, Wenying Jian, Daniel S. Spellman, et al.
Bioanalysis (2023) Vol. 15, Iss. 16, pp. 955-1016
Closed Access | Times Cited: 9
Matt Szapacs, Wenying Jian, Daniel S. Spellman, et al.
Bioanalysis (2023) Vol. 15, Iss. 16, pp. 955-1016
Closed Access | Times Cited: 9
Ultrahigh-Throughput Intact Protein Analysis with Acoustic Ejection Mass Spectrometry
Adway O. Zacharias, Chang Liu, Zachary L. VanAernum, et al.
Journal of the American Society for Mass Spectrometry (2022) Vol. 34, Iss. 1, pp. 4-9
Closed Access | Times Cited: 15
Adway O. Zacharias, Chang Liu, Zachary L. VanAernum, et al.
Journal of the American Society for Mass Spectrometry (2022) Vol. 34, Iss. 1, pp. 4-9
Closed Access | Times Cited: 15
Biomarker Assay Validation by Mass Spectrometry
Carmen Fernández‐Metzler, Brad Ackermann, Fabio Garofolo, et al.
The AAPS Journal (2022) Vol. 24, Iss. 3
Open Access | Times Cited: 8
Carmen Fernández‐Metzler, Brad Ackermann, Fabio Garofolo, et al.
The AAPS Journal (2022) Vol. 24, Iss. 3
Open Access | Times Cited: 8
Comparison of Three Parallelism Assessment Methods of Biomarker Quantification by LC-MS/MS: a Case Study of the Bioanalysis of Creatinine in Human Urine Samples
Xiazi Qiu, John P. Savaryn, Kenneth J. Ruterbories, et al.
Bioanalysis (2022) Vol. 14, Iss. 5, pp. 279-287
Closed Access | Times Cited: 7
Xiazi Qiu, John P. Savaryn, Kenneth J. Ruterbories, et al.
Bioanalysis (2022) Vol. 14, Iss. 5, pp. 279-287
Closed Access | Times Cited: 7
Bioanalysis in the Age of New Drug Modalities
Jing Shi, Xuesong Chen, Jianbo Diao, et al.
The AAPS Journal (2021) Vol. 23, Iss. 3
Open Access | Times Cited: 9
Jing Shi, Xuesong Chen, Jianbo Diao, et al.
The AAPS Journal (2021) Vol. 23, Iss. 3
Open Access | Times Cited: 9
Regen-Cov ® Antibody Cocktail Bioanalytical Strategy: Comparison of Lc-Mrm-Ms and Immunoassay Methods for Drug Quantification
Susan C. Irvin, Samit Ganguly, Rachel Weiss, et al.
Bioanalysis (2021) Vol. 13, Iss. 24, pp. 1827-1836
Open Access | Times Cited: 9
Susan C. Irvin, Samit Ganguly, Rachel Weiss, et al.
Bioanalysis (2021) Vol. 13, Iss. 24, pp. 1827-1836
Open Access | Times Cited: 9
Criteria of Slope and Endogenous Level for Selection of Matrix in the Quantitation of Endogenous Compounds by LC-MS/MS
Allena Ji, Guangxin Xu, Lin Tao, et al.
Bioanalysis (2022) Vol. 14, Iss. 11, pp. 807-816
Open Access | Times Cited: 5
Allena Ji, Guangxin Xu, Lin Tao, et al.
Bioanalysis (2022) Vol. 14, Iss. 11, pp. 807-816
Open Access | Times Cited: 5
Method Development Workflow for Quantifying Protein Biomarkers by Hybrid LC–MS/MS
Karan Agrawal, Yifan Shi, Amanda Del Rosario, et al.
Bioanalysis (2022) Vol. 14, Iss. 14, pp. 985-1004
Closed Access | Times Cited: 5
Karan Agrawal, Yifan Shi, Amanda Del Rosario, et al.
Bioanalysis (2022) Vol. 14, Iss. 14, pp. 985-1004
Closed Access | Times Cited: 5
Hybrid liquid chromatography high resolution and accuracy mass spectrometry approach for quantification of antibody-drug conjugates at the intact protein level in biological samples
Luca Massimo Barbero, Andrea Di Ianni, Francesco Molinaro, et al.
European Journal of Pharmaceutical Sciences (2023) Vol. 188, pp. 106502-106502
Open Access | Times Cited: 2
Luca Massimo Barbero, Andrea Di Ianni, Francesco Molinaro, et al.
European Journal of Pharmaceutical Sciences (2023) Vol. 188, pp. 106502-106502
Open Access | Times Cited: 2
Whole Blood Stability Evaluation of Monoclonal Antibody Therapeutics Using Volumetric Absorptive Microsampling
Hua Li, Maria Myzithras, Erica Bolella, et al.
Bioanalysis (2021) Vol. 13, Iss. 8, pp. 621-629
Closed Access | Times Cited: 6
Hua Li, Maria Myzithras, Erica Bolella, et al.
Bioanalysis (2021) Vol. 13, Iss. 8, pp. 621-629
Closed Access | Times Cited: 6
Therapeutic Drug Monitoring of Antibody Drugs
Atsushi Yonezawa
Biological and Pharmaceutical Bulletin (2022) Vol. 45, Iss. 7, pp. 843-846
Open Access | Times Cited: 4
Atsushi Yonezawa
Biological and Pharmaceutical Bulletin (2022) Vol. 45, Iss. 7, pp. 843-846
Open Access | Times Cited: 4
2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/…
Mike Baratta, Wenying Jian, Shawna Hengel, et al.
Bioanalysis (2024) Vol. 16, Iss. 9, pp. 307-364
Closed Access
Mike Baratta, Wenying Jian, Shawna Hengel, et al.
Bioanalysis (2024) Vol. 16, Iss. 9, pp. 307-364
Closed Access
Microsampling: A role to play in Covid‐19 diagnosis, surveillance, treatment and clinical trials
Madhura Rajadhyaksha, Vaishali Londhe
Drug Testing and Analysis (2021) Vol. 13, Iss. 7, pp. 1238-1248
Closed Access | Times Cited: 5
Madhura Rajadhyaksha, Vaishali Londhe
Drug Testing and Analysis (2021) Vol. 13, Iss. 7, pp. 1238-1248
Closed Access | Times Cited: 5
Detection of antibody-conjugate payload in cynomolgus monkey serum by a high throughput capture LC–MS/MS bioanalysis method
Shujuan Wang, Fengzhu Wang, Ling Wang, et al.
Journal of Pharmaceutical and Biomedical Analysis (2022) Vol. 227, pp. 115069-115069
Closed Access | Times Cited: 3
Shujuan Wang, Fengzhu Wang, Ling Wang, et al.
Journal of Pharmaceutical and Biomedical Analysis (2022) Vol. 227, pp. 115069-115069
Closed Access | Times Cited: 3
The GSK Bioanalytical Hub model in bioanalysis: maximizing the synergies of co-locating various platforms in support of regulated and nonregulated study end points
Scott Summerfield, Huaping Tang, Vilma Decman, et al.
Bioanalysis (2023) Vol. 15, Iss. 3, pp. 127-132
Closed Access | Times Cited: 1
Scott Summerfield, Huaping Tang, Vilma Decman, et al.
Bioanalysis (2023) Vol. 15, Iss. 3, pp. 127-132
Closed Access | Times Cited: 1
N-terminus of Etanercept is Proteolytically Processed by Dipeptidyl Peptidase-4
Sho Masui, Atsushi Yonezawa, Kotoko Yokoyama, et al.
Pharmaceutical Research (2022) Vol. 39, Iss. 10, pp. 2541-2554
Closed Access | Times Cited: 1
Sho Masui, Atsushi Yonezawa, Kotoko Yokoyama, et al.
Pharmaceutical Research (2022) Vol. 39, Iss. 10, pp. 2541-2554
Closed Access | Times Cited: 1
Development and implementation of urinary transporter biomarkers to facilitate assessment of drug–drug interaction
Lina Luo, Manoli Vourvahis, Lauren Horlbogen, et al.
Bioanalysis (2022) Vol. 14, Iss. 14, pp. 971-984
Closed Access | Times Cited: 1
Lina Luo, Manoli Vourvahis, Lauren Horlbogen, et al.
Bioanalysis (2022) Vol. 14, Iss. 14, pp. 971-984
Closed Access | Times Cited: 1