D. Mytych

发表

Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact.

N. Chirmule, S. Tatarewicz, D. Mytych, 2014, Bioanalysis.

Immune Complex Formation Is Associated With Loss of Tolerance and an Antibody Response to Both Drug and Target

Troy E. Barger, H. Hsu, M. C. Teixeira dos Santos, 2021, Frontiers in Immunology.

Immunogenicity assessment of bispecific antibody-based immunotherapy in oncology

H. L. Penny, J. Parnes, M. Kroenke, 2022, Journal for ImmunoTherapy of Cancer.

Immunogenicity and Immune-Related Adverse Drug Reactions

V. Jawa, D. Mytych, L. Mihalcik, 2018 .

Validation parameters for a novel biosensor assay which simultaneously measures serum concentrations of a humanized monoclonal antibody and detects induced antibodies.

D. Mytych, S. Swanson, R. Bordens, 1997, Journal of immunological methods.

Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry

Troy E. Barger, V. Jawa, D. Kuter, 2020, British journal of haematology.

A Proposal to Redefine Clinical Immunogenicity Assessment

M. Kroenke, V. Jawa, D. Mytych, 2017, The AAPS Journal.

Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response.

M. Kroenke, V. Jawa, D. Mytych, 2017, Bioanalysis.

Detection of anti-ESA antibodies in human samples from PRCA and non-PRCA patients: an immunoassay platform comparison.

Troy E. Barger, N. Chirmule, D. Mytych, 2012, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

The Use of Surface Plasmon Resonance for the Detection and Characterization of Antibodies

D. Mytych, S. Swanson, 2011 .

Factors Affecting Circulating mRNA for Nephrin

V. Jawa, S. Tatarewicz, D. Mytych, 2005 .

Cytokines Associated with Increased Erythropoiesis in Sprague-Dawley Rats Administered a Novel Hyperglycosylated Analog of Recombinant Human Erythropoietin

Yudong D. He, Troy E. Barger, S. Elliott, 2014, Toxicologic pathology.

The T-cell-dependent antibody response assay in nonclinical studies of pharmaceuticals and chemicals: study design, data analysis, interpretation.

H. Ochs, H. Lebrec, R. Wange, 2014, Regulatory toxicology and pharmacology : RTP.

Biomarkers for non-human primate type-I hypersensitivity: antigen-specific immunoglobulin E assays.

D. Mytych, M. Hock, C. Forte, 2013, Journal of immunological methods.

A detailed examination of the antibody prevalence and characteristics of anti-ESA antibodies.

Troy E. Barger, D. Mytych, T. Goletz, 2012, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501

G. Fanjiang, H. McBride, Jennifer Liu, 2019, Advances in Therapy.

Comparing ELISA and Surface Plasmon Resonance for Assessing Clinical Immunogenicity of Panitumumab

Arunan Kaliyaperumal, Steven J Swanson, D. Mytych, 2007, The Journal of Immunology.

Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study.

Troy E. Barger, M. Wadhwa, C. Bird, 2016, Journal of immunological methods.

Use of biosensors to monitor the immune response.

J. Ferbas, D. Mytych, S. Swanson, 2002, Developments in biologicals.

Immunogenicity of Panitumumab Resonance for Assessing Clinical Comparing ELISA and Surface Plasmon

D. Mytych, S. Swanson, Christina M Abbott, 2007 .

Phenylazophenol-quinone phenylhydrazone tautomerism in chromogenic cryptands and corands with inward-facing phenolic units and their acyclic analogs

D. Desai, Anand Kumar, E. Luboch, 1991 .

T-cell-dependent antibody responses in the rat: Forms and sources of keyhole limpet hemocyanin matter

J. Reindel, H. Lebrec, M. Joubert, 2014, Journal of immunotoxicology.

Measurement of Anti-Erythropoiesis-Stimulating Agent IgG4 Antibody as an Indicator of Antibody-Mediated Pure Red Cell Aplasia

N. Chirmule, D. Mytych, Narendra Chirmule, 2012, Clinical and Vaccine Immunology.

The development and validation of a sensitive, dual-flow cell, SPR-based biosensor immunoassay for the detection, semi-quantitation, and characterization of antibodies to darbepoetin alfa and epoetin alfa in human serum.

Troy E. Barger, Steven J. Swanson, John Ferbas, 2009, Journal of pharmaceutical and biomedical analysis.

Assessment of romiplostim immunogenicity in pediatric patients in clinical trials and in a global postmarketing registry

Troy E. Barger, M. Tarantino, D. Mytych, 2021, Blood advances.

Risk of pure red cell aplasia in patients with hepatitis C receiving antiviral therapy and an erythropoiesis-stimulating agent.

N. Casadevall, J. Rossert, D. Mytych, 2014, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

Clinical Immunogenicity Risk Assessment for a Fusion Protein

D. Mytych, D. Montgomery, G. Sperinde, 2020, The AAPS Journal.

Clinical validation of the "in silico" prediction of immunogenicity of a human recombinant therapeutic protein.

T. Boone, A. D. De Groot, D. Rivera, 2007, Clinical immunology.

A randomized, double‐blind, single‐dose, three‐arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris®) in healthy male subjects

V. Hanes, D. Chien, D. Mytych, 2020, European journal of haematology.

Development and characterization of a human antibody reference panel against erythropoietin suitable for the standardization of ESA immunogenicity testing.

Troy E. Barger, F. Civoli, R. Haldankar, 2012, Journal of immunological methods.

P055 Immunological cross-reactivity of anti-drug antibodies to adalimumab and ABP 501

N. Zhang, D. Mytych, M. S. Manning, 2018 .

Assessment of the Immunogenicity Potential for Oligonucleotide-Based Drugs.

S. Henry, R. Yu, D. Verthelyi, 2022, Nucleic acid therapeutics.

Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects

J. Gow, J. Gibbs, W. Tsuji, 2015, Arthritis Research & Therapy.

Applications for the new electrochemiluminescent (ECL) and biosensor technologies.

C. Shah, D. Mytych, S. Swanson, 1999, Developments in biological standardization.

Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies.

Vibha Jawa, Michael Moxness, Eugen Koren, 2005, Clinical chemistry.

Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double‐blind Study in Healthy Subjects

J. Franklin, D. Mytych, V. Chow, 2023, Clinical pharmacology in drug development.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

Renuka Pillutla, Viswanath Devanarayan, An Song, 2015, Bioanalysis.

Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions

Cheng-Pang Hsu, D. Mytych, Cheng Peng, 2022, Cephalalgia : an international journal of headache.

Validation of the BIACORE 3000 platform for detection of antibodies against erythropoietic agents in human serum samples

Daniel Mytych, John Ferbas, J. Ferbas, 2003, Current medical research and opinion.

Strategy to confirm the presence of anti-erythropoietin neutralizing antibodies in human serum.

Troy E. Barger, F. Civoli, D. Mytych, 2011, Journal of pharmaceutical and biomedical analysis.

Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager therapy

H. L. Penny, D. Mytych, S. Stienen, 2023, Frontiers in immunology.