47 results on '"Yang, Tong-Yuan"'
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2. An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment aspects of CAR‐T and TCR‐T Cellular Therapies Development
3. Optimization of Peripheral Blood Mononuclear Cell Processing for Improved Clinical ELISpot Assay Performance
4. PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper
5. Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR‐T and TCR‐T Cell Therapies: An Industry Perspective
6. A Phase 1 First‐in‐Human Pharmacokinetic and Pharmacodynamic Study of JNJ‐64264681, a Covalent Inhibitor of Bruton's Tyrosine Kinase
7. Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper
8. Considerations in the Immunogenicity Assessment Strategy for Oligonucleotide Therapeutics (ONTs)
9. Correction: Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma
10. Pharmacokinetic Assays
11. Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma
12. 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)
13. Absorption, Distribution, Metabolism, and Excretion of Therapeutic Proteins: Current Industry Practices and Future Perspectives
14. Characterizing the pharmacokinetics and biodistribution of therapeutic proteins: an industry white paper
15. 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)
16. Considerations in the development and validation of real-time quantitative polymerase chain reaction and its application in regulated bioanalysis to characterize the cellular kinetics of CAR-T products in clinical studies
17. Bifunctional molecules targeting SARS-CoV-2 spike and the polymeric Ig receptor display neutralization activity and mucosal enrichment
18. The first‐in‐human study of CNTO 7160, an anti‐interleukin‐33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis
19. Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products
20. Application of multiplexed pharmacokinetic immunoassay to quantify in vivo drug forms and coadministered biologics
21. 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)
22. Approaches to improve drug tolerance and target tolerance in the assessment of neutralizing anti-drug antibodies
23. Bioanalytical challenges and unique considerations to support pharmacokinetic characterization of bispecific biotherapeutics
24. 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)
25. Application of automated liquid handling in ligand-binding assay-based bioanalytical method development: the practical considerations
26. 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)
27. Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments
28. Monitoring Quality of Critical Reagents Used in Ligand Binding Assays with Liquid Chromatography Mass Spectrometry ( LC ‐ MS )
29. First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis
30. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)
31. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)
32. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)
33. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1 – small molecules by LCMS)
34. Emerging Technologies to Increase Ligand Binding Assay Sensitivity
35. Challenges in selectivity, specificity and quantitation range of ligand-binding assays: case studies using a microfluidics platform
36. A Novel Approach to Evaluate the Pharmacokinetic Biocomparability of a Monoclonal Antibody Derived from Two Different Cell Lines Using Simultaneous Crossover Design
37. Development and validation of ligand-binding assays to support the bioanalysis of therapeutic antibodies
38. Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management
39. A novel approach for the simultaneous quantification of a therapeutic monoclonal antibody in serum produced from two distinct host cell lines
40. Assessment of p53 gene transfer and biological activities in a clinical study of adenovirus-p53 gene therapy for recurrent ovarian cancer
41. The Use of Field Emission Scanning Electron Microscopy to Assess Recombinant Adenovirus Stability
42. Transcriptional Regulation during p21/-induced Apoptosis in Human Ovarian Cancer Cells
43. Aberrant in Vivo T Helper Type 2 Cell Response and Impaired Eosinophil Recruitment in Cc Chemokine Receptor 8 Knockout Mice
44. Leukocytes Expressing Green Fluorescent Protein as Novel Reagents for Adoptive Cell Transfer and Bone Marrow Transplantation Studies
45. Transgenic Expression of the Chemokine Receptor Encoded by Human Herpesvirus 8 Induces an Angioproliferative Disease Resembling Kaposi's Sarcoma
46. The Gfi-1B Proto-Oncoprotein Represses p21WAF1 and Inhibits Myeloid Cell Differentiation
47. Influence of the Host Cell on the Association of ICP4 and ICP0 with Herpes Simplex Virus Type 1
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