№ files_lp_4_process_3_126310
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Evaluation of chronic toxicity study requirements for monoclonal antibodies using a weight-of-evidence model based on prior data, target biology, and pharmacological information.
Year:
2024
Region / City:
Europe
Topic:
Preclinical drug safety assessment
Institution:
Master’s programme, Drug Innovation
Author:
Benedetta Boscolo Todaro
Supervisors:
Hsiao-Tzu Chien, Marieke de Bruin, Peter Van Meer
Target audience:
Regulatory scientists, pharmacologists
Study period:
October 2024 – April 2025
Data analyzed:
42 monoclonal antibodies submitted for EMA approval (2017–2024)
Methodology:
Weight-of-evidence approach, literature review, short-term toxicity studies
Ethical considerations:
Reduction of animal testing, alignment with 3Rs principles
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Region / City:
United States
Topic:
Pharmaceutical naming and regulatory processes
Document type:
Application form
Organization / Institution:
United States Adopted Names Council, American Medical Association
Target audience:
Pharmaceutical companies, researchers, regulatory authorities
Year:
2023
Region / City:
Not specified
Topic:
Monoclonal antibody sequences, growth rate inhibition in cell models
Document type:
Research Supplementary Material
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Researchers, biomedical professionals
Effective period:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2026
Region / City:
Canada, multiple cities
Subject:
COVID-19 treatment eligibility
Document Type:
Medical referral form
Organization / Institution:
Health Canada; regional hospitals
Author:
Clinicians completing referral
Target Audience:
Healthcare providers and eligible patients
Eligibility Criteria:
Adults and pediatric patients ≥12 years, ≥40 kg, at high risk of severe COVID-19
Treatment Window:
Within 7 days of symptom onset
Authorization:
Interim authorization (Interim Order) by Health Canada
Patient Data Fields:
Name, Date of birth, Allergies, Address, Contact information, Health Card Number
Clinical Criteria:
Symptomatic status, vaccination status, comorbidities, immunosuppression, prior COVID-19 infection
Referral Confirmation:
Clinician attestation with signature, date, and College number
Section:
Supplemental Methods
Field:
Immunology and Hematologic Malignancies
Experimental focus:
B7-H3 CAR-T cells in acute myeloid leukemia (AML)
Monoclonal antibodies:
Anti-human CD markers and related reagents for flow cytometry
Suppliers:
Becton-Dickinson (BD) Biosciences; Miltenyi Biotec; BioLegend; Jackson ImmunoResearch Labs
Cell lines:
THP1; U937; HL-60; Kasumi-1; OCI-AML2; OCI-AML3
Primary samples:
DFAM-6855; CBAM-44728 from Public Repository of Xenografts (PRoXe), Dana-Farber Cancer Institute
Biological material:
Primary AML blasts; donor PBMCs; buffy coats from healthy volunteers
Vector system:
SFG retroviral vector with MoMLV gag-pol and RD114 envelope
Transduction method:
Retronectin-coated plates with retroviral supernatant
Cell expansion cytokines:
IL7; IL15
Statistical methods:
Mann Whitney test; one-way ANOVA with Holm-Sidak adjustment; Chi-square test
Software:
Prism version 8 (GraphPad)
Sample origin:
Bone marrow and peripheral blood from AML patients
Animal model:
NSG mice for in vivo expansion of xenografts
Culture conditions:
RPMI-1640 medium with fetal bovine serum, L-glutamine, penicillin, and streptomycin
Year:
2026
Location:
United States
Subject:
Immunology, Monoclonal Antibodies, Mast Cell Biology
Document Type:
Research Supplement / Methods Section
Institution:
Kolltan Pharmaceuticals
Authors:
London et al.
Target Audience:
Scientific researchers in immunology and pharmacology
Experimental Period:
2026
Cell Types:
Human CD34+ progenitor cells, PBMCs, mast cells
Key Techniques:
Flow cytometry, antibody assays, cell differentiation, KIT phosphorylation
Reagents:
KTN0158, KTN0062C, KTN0209, KTN0235, Imatinib, Nilotinib, IL-3, IL-6, SCF, LDL
Year:
2023
Region / City:
Beijing, China
Subject:
Allergic diseases, monoclonal antibody therapy, clinical trials
Document Type:
Supplementary data
Institution:
Capital Medical University, Department of Immunology
Authors:
Yan Chen, Wei Wang, Huihui Yuan, Yan Li, Zhe Lv, Ye Cui, Jie Liu, Sun Ying
Target Population:
Children, adolescents, and adults with allergic asthma
Trial Duration:
12–60 weeks
Primary Outcomes:
Treatment safety, efficacy, quality of life, pulmonary function, IgE levels
Sample Size Range:
19–4308 participants
Medications Studied:
Omalizumab
Study Design:
Controlled clinical trials with specific inclusion criteria for allergic asthma patients
Year:
2026
Research area:
Molecular biology / Cancer research
Document type:
Supplementary figure
Institution:
Unspecified research laboratory
Experimental models:
A549 and HCT116 cancer cell lines
Methods:
Monoclonal antibody production, siRNA knockdown, Simple Western analysis
Compounds tested:
DMSO, M8891
Duration of treatment:
24 hours
Observation period:
96 hours post-knockdown
Controls:
Non-targeting siRNA, γ-tubulin loading control
Visualization software:
Protein Simple Compass
Note:
Year
Region / City:
United States
Topic:
Pharmaceutical naming and regulatory processes
Document type:
Application form
Organization / Institution:
United States Adopted Names Council, American Medical Association
Target audience:
Pharmaceutical companies, researchers, regulatory authorities
Year:
Not specified
Region / city:
Not specified
Topic:
Antibody usage in immunology study
Document type:
Table
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers in immunology
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2025
Region / City:
Northern Victoria
Topic:
Epidemiology, Infectious Diseases, Public Health
Document Type:
Research Study
Author:
Marie Heloury, Joshua Szanyi, Maxwell Braddick, Alexander Fidao, Madeleine J Marsland, Tilda N Thomson, Mitch Batty, Suellen Nicholson, Theo Karapanagiotidis, Kylie Carville, Anna-Jane Glynn-Robinson, Chuan Kok Lim, Naveen Tenneti, Anthony Zheng, William Cross, Jim Black, Helen O’Brien
Target Audience:
Researchers, Public Health Officials, Epidemiologists
Period of Validity:
2023–2024
Date of Approval:
2025-03-25
Date of Changes:
Not specified
Year:
2010
Region / City:
N/A
Subject:
Biomedical Research, Cell Biology, Molecular Biology
Document Type:
Research Methods Supplement
Author:
N/A
Target Audience:
Researchers, Scientists in Biomedical Fields
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2024
Region / city:
India
Topic:
Immunology, Biotechnology
Document type:
Book Chapter
Institution:
Tomo Riba Institute of Health & Medical Sciences (TRIHMS)
Author:
Ashmita Banik
Target audience:
Scientific community, Researchers in Biotechnology and Immunology
Period of validity:
N/A
Approval date:
N/A
Date of changes:
N/A
Section:
Supplemental Methods
Field:
Immunology and Hematologic Malignancies
Experimental focus:
B7-H3 CAR-T cells in acute myeloid leukemia (AML)
Monoclonal antibodies:
Anti-human CD markers and related reagents for flow cytometry
Suppliers:
Becton-Dickinson (BD) Biosciences; Miltenyi Biotec; BioLegend; Jackson ImmunoResearch Labs
Cell lines:
THP1; U937; HL-60; Kasumi-1; OCI-AML2; OCI-AML3
Primary samples:
DFAM-6855; CBAM-44728 from Public Repository of Xenografts (PRoXe), Dana-Farber Cancer Institute
Biological material:
Primary AML blasts; donor PBMCs; buffy coats from healthy volunteers
Vector system:
SFG retroviral vector with MoMLV gag-pol and RD114 envelope
Transduction method:
Retronectin-coated plates with retroviral supernatant
Cell expansion cytokines:
IL7; IL15
Statistical methods:
Mann Whitney test; one-way ANOVA with Holm-Sidak adjustment; Chi-square test
Software:
Prism version 8 (GraphPad)
Sample origin:
Bone marrow and peripheral blood from AML patients
Animal model:
NSG mice for in vivo expansion of xenografts
Culture conditions:
RPMI-1640 medium with fetal bovine serum, L-glutamine, penicillin, and streptomycin
Year:
2026
Region / City:
Not specified
Subject:
Clinical diagnostics, virology
Document Type:
In vitro diagnostic test instructions
Organization:
ZEUS Scientific, Inc.
Author:
Not specified
Target Audience:
Laboratory personnel
Period of Use:
Ongoing
Date of Issue:
2026
Safety Precautions:
Biosafety Level 2, toxic and irritant reagents handling instructions included
Components:
Microplate strips, conjugate, controls, calibrator, diluent, substrate, stop solution, wash buffer
Intended Sample:
Human serum
Test Principle:
ELISA detection of IgG antibodies to EBV Nuclear Antigen 1 (EBNA-1)
Assay Procedure:
Three-step incubation with antigen-coated wells, conjugate, and substrate followed by photometric measurement
Study title:
Prevalence of Pathogenic Antibodies in Psychosis 2 (PPiP2)
Principal Investigator:
Local PPiP2 researcher
Participant study ID:
[ID]
Date:
[Date]
Version:
[Version]
Year:
[Year]
Region / City:
[Region or city if mentioned]
Topic:
Medical Research, Psychiatric Studies
Document Type:
Consent Form
Institution:
University of Oxford
Author:
[Author(s) if available]
Target Audience:
Research Participants, Medical Professionals
Study Period:
[Study Period if mentioned]
Approval Date:
[Date of approval if mentioned]
Amendment Date:
[Date of amendments if mentioned]
Year:
Not specified
Region / city:
Not specified
Topic:
Environmental, Social, Economic Impacts of Chemical & Pharmaceutical Products
Document Type:
Environmental/Social/Economic Impact Analysis
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Not specified
Effective Date:
Not specified
Date of Changes:
Not specified
Contextual description:
Environmental, social, and economic impact analysis of chemical and pharmaceutical products.
Year:
2026
Region / City:
Not specified
Field:
Immunology / Molecular Biology
Document Type:
Supplementary Table
Institution:
Not specified
Authors:
Not specified
Target Audience:
Researchers in immunology and molecular biology
Reagents Included:
Antibodies, Chemicals, Peptides, Recombinant Proteins, Additional Reagents, Critical Commercial Assays
Organism:
Mouse
Experimental Context:
T cell characterization and immunological assays
Source:
Multiple commercial suppliers listed for each reagent