GLP and Non-GLP TOxicology Studies
Southern Research offers Toxicology and Safety Assessment services, providing critical support for IND-enabling studies and regulatory submissions. Leveraging extensive GLP experience and flexible study designs, our expert team delivers precise, reliable data. From small to large animal studies, we ensure the highest quality and compliance standards throughout your drug development journey.
What Sets Us Apart:
Toxicology
Expertise in comprehensive toxicology assessments designed to meet rigorous GLP and non-GLP regulatory requirements, enabling smooth and successful IND submissions.
- IND-Enabling Toxicology Studies
- Non-GLP and GLP Toxicology Studies
- Dose Range Finding Studies
- Maximum Tolerated Dose Studies
- Acute and chronic toxicology
- Immunogenicity
- Immunohistochemistry
- Specialized Necropsy
- Histopathology
- Clinical pathology
- PK/TK data analysis
Biodistribution/Pharmacodynamic and Pharmacokinetic
Expertise in determining PD and PK for a variety of test articles using the latest technologies and approaches.
- In vivo optical imaging system (IVIS)
- Positron Emission Topography (PET)
- Quantitative whole body radiography (QWBA)
- Tissue bioanalysis using research grade, qualified or validated methods
Models and dosing routes
Decades of expertise in all major in vivo models with standard and novel dosing routes.
Models
- NHPs
- Cynomologus macaque (Southeast Asian and Mauritian origin)
- African green/Chlorocebus aethiops
- Rhesus macaque
- Canine
- Rat
- Mouse
- Ferret
- Rabbit
- Cotton Rat
Routes of Administration
- Subcutaneous
- Oral gavage
- Intradermal
- Tail vein
- Intravenous
- Intramuscular
- Dermal
- Inhalation
- Nasal
- Intrathecal
- Intracranical
- Intracerebral ventricular
Preclinical and Clinical Bioanalytical and Biomarker Assays
Expertise in a variety of research grade, qualified and validated assay types for most test article types.
- PCR Assays via qPCR and RT-qPCR
- Isolation and quantitation of DNA & RNA
- High-throughput sample processing
- Quantify genomic and sub-genomic targets
- Investigate target biodistribution and gene expression
- Quantify viral or vector loads
- Perform genotyping and transcriptional analysis
- Ligand Binding Assays
- Platforms include ELISA, MSD, and Luminex
- Non-GLP and GLP PK and biomarker assays
- Clinical trial support, Phase I-IV
- Biomarker characterization, including multiplex & single-plex biomarker analysis
- Immunological Assessments
- Detect, measure, and characterize antibody responses
- Capture acute phase responses
- Evaluate immunotoxicity
- Multiplex cytokine & chemokine analysis
- Multiplex & single-plex biomarker analysis
- Identify and enumerate cell subpopulations using 13 color flow cytometry
- Develop custom functional assays
- Conduct immune cell functional assays evaluating neutrophil & macrophage activation and target killing, T cell proliferation, NK cell assay
- Anti-Drug Antibody (ADA) assays
BSL-1/BSL-2/BSL-3 Specialized Capabilities
Conduct specialized vaccine safety and infectious disease studies safely and effectively in our state-of-the-art BSL-1, BSL-2 and BSL-3 facilities.
Vaccine Safety & Neurovirulence Testing
Unique expertise in assessing vaccine safety, including specialized neurovirulence studies, supporting successful regulatory submissions and approvals.
Partnering for Toxicology Excellence and Regulatory Success
With extensive GLP experience, proven regulatory expertise, and flexible testing options, Southern Research is your ideal partner for comprehensive toxicology evaluations. Our experienced scientific team helps optimize study design, streamlining your path to successful regulatory outcomes.
IND-Enabling Toxicology Expertise
Accelerate your drug development programs with comprehensive IND-enabling toxicology studies, precisely tailored to domestic and global regulatory standards.
Rapid PK & Dose-Range Finding Studies
Swiftly progress your programs with rapid-turnaround pharmacokinetic (PK) and dose-range finding studies, supported by our reliable in vivo testing capabilities.
Our Experts
Donghui Bao, Ph.D.
Erin Luea
Ready to Advance Your Research?
Contact our experts today and explore how Southern Research can elevate your project.