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Requested Article:
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)
Susan Spitz, Yan Zhang, Sally Fischer, et al.
Bioanalysis (2021) Vol. 13, Iss. 5, pp. 295-361
Closed Access | Times Cited: 24
Susan Spitz, Yan Zhang, Sally Fischer, et al.
Bioanalysis (2021) Vol. 13, Iss. 5, pp. 295-361
Closed Access | Times Cited: 24
Showing 24 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: 7
Johanna Mora, Rachel Palmer, Leslie Wagner, et al.
Bioanalysis (2024) Vol. 16, Iss. 7, pp. 77-119
Closed Access | Times Cited: 7
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: 7
Olga Kholmanskikh, Yow‐Ming Wang, Sarah Hersey, et al.
Bioanalysis (2024) Vol. 16, Iss. 8, pp. 179-220
Open Access | Times Cited: 7
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: 26
LiNa Loo, Shannon Harris, Mark Milton, et al.
Bioanalysis (2022) Vol. 14, Iss. 11, pp. 737-793
Closed Access | Times Cited: 26
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 | Times Cited: 5
Mike Baratta, Wenying Jian, Shawna Hengel, et al.
Bioanalysis (2024) Vol. 16, Iss. 9, pp. 307-364
Closed Access | Times Cited: 5
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: 21
Surinder Kaur, Stephen C. Alley, Matt Szapacs, et al.
Bioanalysis (2022) Vol. 14, Iss. 9, pp. 505-580
Closed Access | Times Cited: 21
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: 19
Sarah Hersey, Steve Keller, Joel Mathews, et al.
Bioanalysis (2022) Vol. 14, Iss. 10, pp. 627-692
Closed Access | Times Cited: 19
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: 11
Giane Sumner, Steve Keller, James W. Huleatt, et al.
Bioanalysis (2023) Vol. 15, Iss. 15, pp. 861-903
Closed Access | Times Cited: 11
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: 11
Matt Szapacs, Wenying Jian, Daniel S. Spellman, et al.
Bioanalysis (2023) Vol. 15, Iss. 16, pp. 955-1016
Closed Access | Times Cited: 11
Recommendations on biomarker assay validation (BAV) in tissues by GCC
Moucun Yuan, Aihua Liu, Bin Xu, et al.
Bioanalysis (2025), pp. 1-10
Closed Access
Moucun Yuan, Aihua Liu, Bin Xu, et al.
Bioanalysis (2025), pp. 1-10
Closed Access
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
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: 10
Luying Pan, Johanna Mora, Karl Walravens, et al.
Bioanalysis (2023) Vol. 15, Iss. 14, pp. 773-814
Closed Access | Times Cited: 10
Validation of a 12‐color flow cytometry assay for acute myeloid leukemia minimal/measurable residual disease detection
Sa A. Wang, Jeffrey L. Jorgensen, Shimin Hu, et al.
Cytometry Part B Clinical Cytometry (2023) Vol. 104, Iss. 5, pp. 356-366
Closed Access | Times Cited: 10
Sa A. Wang, Jeffrey L. Jorgensen, Shimin Hu, et al.
Cytometry Part B Clinical Cytometry (2023) Vol. 104, Iss. 5, pp. 356-366
Closed Access | Times Cited: 10
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: 11
Carmen Fernández‐Metzler, Brad Ackermann, Fabio Garofolo, et al.
The AAPS Journal (2022) Vol. 24, Iss. 3
Open Access | Times Cited: 11
Internal standard variability: root cause investigation, parallelism for evaluating trackability and practical considerations
Jinhui Zhang, Arindam Dasgupta, Ruben Ayala, et al.
Bioanalysis (2024), pp. 1-6
Closed Access | Times Cited: 2
Jinhui Zhang, Arindam Dasgupta, Ruben Ayala, et al.
Bioanalysis (2024), pp. 1-6
Closed Access | Times Cited: 2
Biosimilars in the Era of Artificial Intelligence—International Regulations and the Use in Oncological Treatments
Tomás Gabriel Bas, Vannessa Duarte
Pharmaceuticals (2024) Vol. 17, Iss. 7, pp. 925-925
Open Access | Times Cited: 2
Tomás Gabriel Bas, Vannessa Duarte
Pharmaceuticals (2024) Vol. 17, Iss. 7, pp. 925-925
Open Access | Times Cited: 2
A human receptor occupancy assay to measureanti‐PD ‐1 binding in patients with prioranti‐PD ‐1
Fabian Junker, Pratiksha Gulati, Uwe Wessels, et al.
Cytometry Part A (2021) Vol. 99, Iss. 8, pp. 832-843
Open Access | Times Cited: 14
Fabian Junker, Pratiksha Gulati, Uwe Wessels, et al.
Cytometry Part A (2021) Vol. 99, Iss. 8, pp. 832-843
Open Access | Times Cited: 14
Determination of label efficiency and label degree of critical reagents by LC-MS and native MS
Katie Carle, John F. Kellie, George R. Gunn, et al.
Analytical Biochemistry (2022) Vol. 664, pp. 115033-115033
Closed Access | Times Cited: 6
Katie Carle, John F. Kellie, George R. Gunn, et al.
Analytical Biochemistry (2022) Vol. 664, pp. 115033-115033
Closed Access | Times Cited: 6
Current and Effective Strategies for Critical Reagent Characterization, Storage, Stability, Retesting and Life Cycle Management for Ligand-Binding Assays and Flow Cytometry
Lakshmi Amaravadi, Nisha Palackal, Fabio Garofolo
Bioanalysis (2021) Vol. 13, Iss. 10, pp. 737-740
Closed Access | Times Cited: 4
Lakshmi Amaravadi, Nisha Palackal, Fabio Garofolo
Bioanalysis (2021) Vol. 13, Iss. 10, pp. 737-740
Closed Access | Times Cited: 4
Long term investigation of formulation buffers to mitigate stability issues of conjugated critical reagents
Glenn T Miller, Teresa Caiazzo, Alison Joyce
Journal of Immunological Methods (2024) Vol. 533, pp. 113742-113742
Closed Access
Glenn T Miller, Teresa Caiazzo, Alison Joyce
Journal of Immunological Methods (2024) Vol. 533, pp. 113742-113742
Closed Access
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
Comparison of highly sensitive, multiplex immunoassay platforms for streamlined clinical cytokine quantification
Kevin McKinski, Huaping Tang, Kai Wang, et al.
Bioanalysis (2024), pp. 1-13
Closed Access
Kevin McKinski, Huaping Tang, Kai Wang, et al.
Bioanalysis (2024), pp. 1-13
Closed Access
Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?
Amanda Hays, Lakshmi Amaravadi, Carmen Fernández‐Metzler, et al.
The AAPS Journal (2022) Vol. 24, Iss. 3
Closed Access | Times Cited: 1
Amanda Hays, Lakshmi Amaravadi, Carmen Fernández‐Metzler, et al.
The AAPS Journal (2022) Vol. 24, Iss. 3
Closed Access | Times Cited: 1
Approaches to Overcome the Challenge of Sample Stability for Flow Cytometry Analysis in Clinical Trials
Amanda Hays
Bioanalysis (2021) Vol. 13, Iss. 21, pp. 1587-1589
Closed Access | Times Cited: 1
Amanda Hays
Bioanalysis (2021) Vol. 13, Iss. 21, pp. 1587-1589
Closed Access | Times Cited: 1
Welcome to volume 14 of Bioanalysis
Sankeetha Nadarajah
Bioanalysis (2021) Vol. 14, Iss. 1, pp. 1-5
Closed Access
Sankeetha Nadarajah
Bioanalysis (2021) Vol. 14, Iss. 1, pp. 1-5
Closed Access