Reduce Timelines with Integrated Toxicology
How much can you accomplish in six months?
Making go, no-go decisions are critical when developing new therapies and doing so within the rapid timeline is even more critical. With Charles River's integrated toxicology, you can launch non-clinical studies in just four days. Gain real-time data access, receive comprehensive reports in 10 days, and accelerate your path to the clinic. Our Kansas facility boasts advanced automation and a team of scientific experts, delivering faster, robust data to de-risk your development program early. Skip the six-month wait for exploratory toxicology data. Unlock the power of speed and efficiency with integrated toxicology offering in Kansas.
The ability to conduct lead optimization toxicology in a digitally enabled facility with automation, workflow efficiencies, and a dedicated team that provides robust data quickly; thereby accelerating the drug development timeline.
10 Regulatory Truths for Biotech Founders
Do not leave your breakthrough to a chance; download this complimentary infographic as a concise checklist to help you stay on track and reach your milestones.
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Template Study Designs and Reports
Our non-GLP toxicology studies, including in vivo toxicology evaluations, are designed for flexibility and efficiency. These non-GLP toxicology studies use simplified protocol (study plan) templates and corresponding abbreviated report formats. The simplified formats are designed for the evaluation of key objectives while allowing design flexibility in design to address milestone goals and endpoints for your test article/item. Using streamlined designs that focus on preliminary evaluation of key endpoints allows for studies to be initiated quickly and efficiently.
Our expertise spans a comprehensive range of in vivo non-GLP and GLP safety assessment solutions in both rodent and non-rodent species. This enables us to thoroughly evaluate pharmaceuticals, biologics, animal health products, agrochemicals, and biocides, providing robust data to inform your development decisions.
WEBINAR: Maximize Safer, Targeted Biologic Development with Smarter NAMs-Based Off-Target Screening
This webinar showcases how the Retrogenix® platform empowers smarter, earlier decisions across biologic formats. You’ll also learn how this platform, recently accepted into the FDA’s ISTAND Pilot Program, aligns with evolving regulatory support for NAMs and the shift toward reduced animal use.
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Streamlined Processes and Documentation
Studies are easier to initiate and execute, as well as have reduced and more efficient handoffs for data collection and review. We have a nimble and dedicated staff available to perform multiple functions resulting in simplified processes and client interactions.
Non-GLP Toxicology Study Outlines and What to Expect
The following specialty groups provide rapid study starts, complete with the evaluations listed below to provide drug developers with data to make critical go/no-go decisions.
- Formulation development, pharmacy, and analytical chemistry
- Bioanalysis
- Histology
- Clinical Pathology
- Digital Pathology
- Reporting
Non-GLP Toxicology Studies Offered:
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General Studies:
- HT- In Vitro ADME
- In Vitro ADME
- Drug Transporter Assays
- In Vivo ADME (Non-Radiolabeled)
- In Vivo ADME (Radiolabeled)
- QWBA
- Tissue Distribution
- Metabolite Profiling and Structural Elucidation
- PK/TK Workup of bioA Data (Watson or Phoenix WNL)
- Radioanalysis
- Skin Penetration
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Bioanalysis and Related:
- Discovery/nonGLP Bioanalysis (RGA 1,2,3) small molecule
- Discovery/nonGLP Bioanalysis (RGA 1,2,3) peptides
- Discovery/nonGLP Bioanalysis (RGA 1,2,3) biotherapeutics
- Discovery/nonGLP Bioanalysis (RGA 1,2,3) gene therapies (siRNA/oligos/etc)
- Dose Formulation Analysis (LC-MS based; along with the study samples)
- Dose Formulation Analysis (pre-study analysis; UV-VIS)
- nonGLP Bioanalysis small molecule
- nonGLP Bioanalysis peptides
- nonGLP Bioanalysis biotherapuetics
- nonGLP Bioanalysis gene therapies (siRNA/oligos/etc)
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in-vivo Studies:
- Rapid Pharmacokinetic Screening
- Small molecule nonGLP PK/PD
- Large molecule nonGLP PK/PD
- Small molecule GLP PK/PD
- Large molecule GLP PK/PD
- Species - Rodent
- Species - NHP
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in-vitro Studies:
- Flow cytometry
- Imaging
- ELISA
- MSD
- Cell proliferation assay
- Cytotoxic T-lymphocyte (CTL) assay
- In vitro drug screen
- In vitro cell differentiation
- Cell phagocytosis
- Cell isolation
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Oncology:
- nonGLP PK/PD and efficacy studies
- Syngeneic models In immune competent strains
- Xenograft models
- Humanized models
- Transgenic models
- Knock-out/Knock-In models
- Antibiotic-treated mice for microbiome studies; multiple modalities
- Pathology:
Your Guide to General Toxicology
This brochure outlines our general toxicology services while sharing challenges and advantages with Charles River conducting your general toxicology services.
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Frequently Asked Questions (FAQs) About Non-GLP Toxicology
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Are SEND datasets required for non-GLP preclinical studies?
Yes, SEND is required for both GLP and non-GLP preclinical studies when the study design is in-scope for SEND. Both GLP and non-GLP preclinical studies may be submitted to FDA to support clinical safety, so the decision to include SEND is independent of GLP status.
Understanding SEND: Ensure Your Dataset Complies with the Most Recent Updates
Learn how to effectively navigate the evolving regulatory landscape with advice from SEND experts in this webinar on demand.
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What is non-GLP toxicology testing?
A non-GLP toxicology study maintains the same high level of study conduct and execution, but is not needed to comply with all GLP requirements. These toxicology studies are performed to high standards of quality to ensure accurate and reliable study data that are needed to evaluate your test article/item.
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What is GLP versus non-GLP toxicology testing?
Good Laboratory Practice (GLP) regulations outline study conduct and documentation practices to ensure that studies can be reconstructed and repeated in a reliable fashion. The purpose of the regulations is not to provide data interpretation guidance nor dictate the safety characteristics of the test article/item.
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How do you test non-GLP toxicity?
Non-GLP toxicity studies are traditionally short (less than two weeks) and designed to identify major issues that could impede the development of your test article/item. The study designs have limited animal numbers and limited endpoints including, but not limited to, clinical observations, food consumption, body weights, toxicokinetics, clinical pathology, and limited histopathology (limited to major organs). Also, the study may be designed to help identify doses for longer duration GLP studies.