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Assess Your Compound’s MOA Through Gene Expression Profiling
Inotiv’s toxicogenomics studies are a powerful tool for the safety assessment of preclinical candidates, as well as novel small molecule and commodity chemicals. Data can be used to:
- Establish mode-of-action (MOA) for target and off-target effects
- Identify early potential liabilities of preclinical candidates in pharmaceutical development
- Identify common response pathway(s) for development of gene signature biomarkers
- Enable early safety assessment in discovery toxicology using high-throughput targeted gene expression
- Determine quantitative benchmark dose (BMD) relationships between-dose and gene-expression based pathway responses for use in risk assessments
Our experimental designs for toxicogenomic studies employ dose-response studies — from human-relevant levels to exposure levels used in regulatory studies — with a focus on identifying no-observed-effect level (NOEL) and benchmark doses useful in risk assessments, as well as determining thresholds of toxicological concern.
With a deep background in toxicogenomics and genetic and molecular toxicology, our team conducts studies aimed at identifying cellular and genomic response pathways to xenobiotic exposures.
Our fully integrated capabilities deliver turnkey toxicology solutions that include gene expression profiling integrated into traditional studies. We design studies for:
- Optimal downstream statistical evaluation
- Processing samples by next-generation sequencing
- Bioinformatics support to determine biological relevance and significance of the data
- A comprehensive investigative toxicology approach to assess MOA
- Applying computational tools using a broad spectrum of in vitro and in vivo test systems
- Integrating genomic profiling into traditional toxicology studies
- Integrating traditional apical endpoints with histology and pathology support
Inotiv’s scientific staff has the expertise to provide a comprehensive investigative toxicology approach to assess MOA. We integrate genomic profiling into traditional toxicology studies and apply computational tools using a broad spectrum of in vitro and in vivo models.
Our studies provide data in a timely manner to improve your understanding of potential adverse effects. We ensure you understand how the data are relevant to humans to facilitate informed decision-making.
To talk to an expert about our Toxicogenomic Services, please click here.
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Nucleic Acid purification and analysis
- Isolation of RNA or DNA from animal tissues, blood, cultured cells, and formalin-fixed, paraffin-embedded (FFPE) tissue
- Agilent Bioanalyzer assessment of nucleic acid purity and integrity
- Agarose and PAGE gel electrophoresis
Next-generation sequencing technology
- Illumina NextSeq® 500
- DNA and RNA library preparation
- Whole transcriptome sequencing (RNA-Seq)
- Preparation of libraries from FFPE-derived DNA/RNA
- Whole exome and amplicon DNA-Seq
- High-throughput targeted gene expression
Gene expression/detection via PCR
- Quantitative real-time PCR (TaqMan® and SYBR® Green chemistries)
- Applied Biosystems microfluidic arrays
- Detection and quantitation of specific mRNA and lncRNA species
- Design of PCR assays for use with samples from FFPE tissues
- Design of complex PCR assays for genes with significant homology to other genes or pseudogenes
- Bioinformatics support
Genetic Toxicology
Genetic Toxicology
Inotiv provides a complete Genetic Toxicology solution, including non-GLP screening, all required in vitro and invivo regulatory assays and follow-up/secondary testing
Predictive and Computational Toxicology
Predictive and Computational Toxicology
Inotiv's computational toxicology group offers you a wide range of expertise across informatics areas, allowing us to draw on data from your assays, in-house resrouces, and relevant literature to deliver the insights you need
Toxicogenomics
Toxicogenomics
Inotiv's toxicogenomics studies are a powerful tool for the safety assessment of preclinical candidates, as well as novel small molecule and commodity chemicals.
General Toxicology
General Toxicology
Inotiv offers a range of general toxicology studies to evaluate the safety of drugs, medical devices, and other chemicals. We design and conduct studies according to international regulations and our toxicology expertise can help assess potential risks and ensure the safety of your product.
Histology
Histology
Projects with a wide range of services. From tissue processing to digital analysis, our team delivers the quality you expect.
Pathology
Pathology
Access world-class anatomical, clinical, and medical device pathology services, from routine histochemistry, IHC, IF, and ISH to stereology.
