Search Results - "Partridge MA"

Immunogenicity assessment for vidutolimod: a risk-driven approach for a simplified 1-tiered, singlicate anti-drug antibody testing strategy.

Authors: Valentine JL Shank S Fred Lucena LM et al.

Source: Frontiers in immunology [Front Immunol] 2026 May 19; Vol. 17, pp. 1751717. Date of Electronic Publication: 2026 May 19 (Print Publication: 2026).

Publication Type: Journal Article

Journal Info: Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101560960 Publication Model: eCollection Cited Medium: Internet ISSN: 1664-3224 (Electronic) Linking ISSN: 16643224 NLM ISO Abbreviation: Front Immunol Subsets: MEDLINE

The role of large immune complexes in anti-drug antibody development: a case study of anti-SARS-CoV-2 antibody therapeutics and co-administered mRNA vaccine.

Authors: Irvin SC Wang Z Ganguly S et al.

Source: Frontiers in immunology [Front Immunol] 2026 Mar 10; Vol. 17, pp. 1769163. Date of Electronic Publication: 2026 Mar 10 (Print Publication: 2026).

Publication Type: Journal Article

Journal Info: Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101560960 Publication Model: eCollection Cited Medium: Internet ISSN: 1664-3224 (Electronic) Linking ISSN: 16643224 NLM ISO Abbreviation: Front Immunol Subsets: MEDLINE

Summary of Research: Immunogenicity of Dupilumab in Adult and Pediatric Patients with Atopic Dermatitis.

Authors: Kosloski MP Lai CH Partridge MA et al.

Source: Dermatology and therapy [Dermatol Ther (Heidelb)] 2026 Jun; Vol. 16 (6), pp. 2603-2606. Date of Electronic Publication: 2026 Apr 29.

Publication Type: Journal Article

Journal Info: Publisher: Springer Healthcare Communications Country of Publication: Switzerland NLM ID: 101590450 Publication Model: Print-Electronic Cited Medium: Print ISSN: 2193-8210 (Print) NLM ISO Abbreviation: Dermatol Ther (Heidelb) Subsets: PubMed not MEDLINE

Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing.

Authors: Zhao A Bond S Clausen V et al.

Source: The AAPS journal [AAPS J] 2026 May 19; Vol. 28 (4). Date of Electronic Publication: 2026 May 19.

Publication Type: Journal Article; Review

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report.

Authors: Shubow S Gunsior M Rosenberg A et al.

Source: The AAPS journal [AAPS J] 2025 Mar 14; Vol. 27 (2), pp. 62. Date of Electronic Publication: 2025 Mar 14.

Publication Type: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials.

Authors: Lai CH Chen M Fraser S et al.

Source: The AAPS journal [AAPS J] 2024 Dec 12; Vol. 27 (1), pp. 11. Date of Electronic Publication: 2024 Dec 12.

Publication Type: Journal Article; Research Support, Non-U.S. Gov't

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis.

Authors: Kamal MA Kosloski MP Lai CH et al.

Source: Frontiers in immunology [Front Immunol] 2024 Nov 11; Vol. 15, pp. 1466372. Date of Electronic Publication: 2024 Nov 11 (Print Publication: 2024).

Publication Type: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial

Journal Info: Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101560960 Publication Model: eCollection Cited Medium: Internet ISSN: 1664-3224 (Electronic) Linking ISSN: 16643224 NLM ISO Abbreviation: Front Immunol Subsets: MEDLINE

Assessment of Immune Responses Against AAV Encoded Transgene Products.

Authors: Gorovits B Azadeh M Fiscella M et al.

Source: The AAPS journal [AAPS J] 2026 Jan 05; Vol. 28 (1), pp. 43. Date of Electronic Publication: 2026 Jan 05.

Publication Type: Journal Article; Review

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (PART 3A - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

Authors: Tounekti O Shubow S Wassmer S et al.

Source: Bioanalysis [Bioanalysis] 2025 Nov; Vol. 17 (22), pp. 1365-1409. Date of Electronic Publication: 2026 Jan 06.

Publication Type: Journal Article

Journal Info: Publisher: Taylor & Francis Country of Publication: England NLM ID: 101512484 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1757-6199 (Electronic) Linking ISSN: 17576180 NLM ISO Abbreviation: Bioanalysis Subsets: MEDLINE

Association of Immunogenicity and Drug Exposure and the Importance of Target Engagement in ADA Development: A Clinical Case Study of Anti-SARS-CoV-2 Biotherapeutics.

Authors: Irvin SC Ganguly S Wang Z et al.

Source: The AAPS journal [AAPS J] 2025 Oct 23; Vol. 28 (1), pp. 2. Date of Electronic Publication: 2025 Oct 23.

Publication Type: Journal Article

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays.

Authors: Partridge MA Kamen L Wu B et al.

Source: The AAPS journal [AAPS J] 2025 Aug 13; Vol. 27 (5), pp. 132. Date of Electronic Publication: 2025 Aug 13.

Publication Type: Journal Article; Review

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development.

Authors: Davis JD Bravo Padros M Conrado DJ et al.

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Mar; Vol. 115 (3), pp. 422-439. Date of Electronic Publication: 2024 Jan 10.

Publication Type: Journal Article; Review; Research Support, Non-U.S. Gov't

Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE

Immunogenicity of Cemiplimab: Low Incidence of Antidrug Antibodies and Cut-Point Suitability Across Tumor Types.

Authors: Valentine JL Dengler A Zhao A et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2024 Jan; Vol. 64 (1), pp. 125-136. Date of Electronic Publication: 2023 Sep 20.

Publication Type: Journal Article; Research Support, Non-U.S. Gov't

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

Authors: Tounekti O Prior S Wassmer S et al.

Source: Bioanalysis [Bioanalysis] 2025 Feb; Vol. 17 (3), pp. 105-149. Date of Electronic Publication: 2025 Jan 25.

Publication Type: Journal Article; Consensus Statement

Journal Info: Publisher: Taylor & Francis Country of Publication: England NLM ID: 101512484 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1757-6199 (Electronic) Linking ISSN: 17576180 NLM ISO Abbreviation: Bioanalysis Subsets: MEDLINE

Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal.

Authors: Garlits J McAfee S Taylor JA et al.

Source: The AAPS journal [AAPS J] 2023 Apr 04; Vol. 25 (3), pp. 37. Date of Electronic Publication: 2023 Apr 04.

Publication Type: Journal Article; Research Support, Non-U.S. Gov't

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium.

Authors: Starcevic Manning M Hassanein M Partridge MA et al.

Source: The AAPS journal [AAPS J] 2022 Jul 12; Vol. 24 (4), pp. 81. Date of Electronic Publication: 2022 Jul 12.

Publication Type: Journal Article; Research Support, Non-U.S. Gov't

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay.

Authors: Partridge MA Chen J Karayusuf EK et al.

Source: The AAPS journal [AAPS J] 2022 Jul 01; Vol. 24 (4), pp. 78. Date of Electronic Publication: 2022 Jul 01.

Publication Type: Journal Article

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy.

Authors: Irvin SC D'Orvilliers A Bloch N et al.

Source: The AAPS journal [AAPS J] 2022 Jun 21; Vol. 24 (4), pp. 76. Date of Electronic Publication: 2022 Jun 21.

Publication Type: Journal Article

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays.

Authors: Dengler AF Weiss R Truong T et al.

Source: The AAPS journal [AAPS J] 2021 Oct 04; Vol. 23 (6), pp. 109. Date of Electronic Publication: 2021 Oct 04.

Publication Type: Journal Article; Research Support, Non-U.S. Gov't

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry.

Authors: Huang X Xu X Partridge MA et al.

Source: The AAPS journal [AAPS J] 2021 Jan 06; Vol. 23 (1), pp. 16. Date of Electronic Publication: 2021 Jan 06.

Publication Type: Journal Article

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE