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CYP Induction Studies
A standard in vitro assay for drug-drug interaction (DDI)
- CYP Induction studies
De-risking drug-drug interactions risk for regulatory success
Understanding how a drug may impact the body’s metabolic system is a key part of developing safe and effective therapies. At Concept Life Sciences, we offer reliable, cost effective and regulatory-aligned CYP induction studies to help you assess the potential for drug-drug interactions risk early in discovery and ensure compliance with FDA/EMA regulatory expectations.
Key benefits
- Predicts DDI risk early in development using clinically relevant human hepatocytes
- Mechanistic support for regulatory submissions
- Flexible early phase screening or full-panel formats for early or late-stage programs
- De-risk your development program and support confident decision-making
- Fully aligned with FDA and EMA guidance for regulatory submissions
- GLP-compliant workflow on request
- Target clients in preclinical or IND-enabling stages, especially those submitting to regulators
Protocol
Our team focuses on the most clinically relevant CYP450 enzymes - CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4 using well-established in vitro models like cryopreserved human hepatocytes. Cells are treated with test compounds for 48 – 72 hours (media refreshed daily), and induction is quantified at gene and enzyme activity levels to provide a comprehensive view of metabolic response. We measure changes in enzyme activity, mRNA levels, cytotoxicity and protein expression to provide a full picture of induction potential.
- Preliminary Test Item Solubility assessment assay
- Preliminary Cytotoxicity Assessment (ATP assay and/or LDH Release
- Tier 1: Verified lots of Pooled Human hepatocytes; 48 h treatment; 7 Concentrations of test item (n=3); one conc. positive and negative control; Designed for decision making; Data package/full report.
- Tier 2: Primary Human Hepatocytes from 3 Human donors; 72 h treatment; 7 Concentrations of test item (n=3); one conc. positive and negative control; Designed for IND enabling Regulatory compliant submissions; Full Report.
Endpoints
- mRNA Expression (qRT-PCR)
- Catalytic Activity (LC-MS/MS)
Compound requirements
Test systems
Assay format
Controls
Quantitation
Deliverables
Data analysis and results
Data are evaluated against vehicle and reference inducers (e.g., rifampicin, β-naphthoflavone, phenobarbital). Results include fold induction vs. control, Emax/EC50 calculations (4-parameter nonlinear fit), and statistical normalization across donors.
Data Output
- Fold induction vs. vehicle control
- Emax, EC50 (4-parametric nonlinear fit, if applicable)
- Raw and summary Excel data
- Optional full written report
Conclusions
These insights help de-risk your development program and support confident decision-making as you move your compounds forward. Our CYP induction studies provide critical insights into metabolic interactions, helping you:
- Identify and mitigate DDI risks early
- Streamline regulatory submissions
- Advance compounds with confidence
Partner with Concept Life Sciences to navigate the complexities of CYP induction with clarity, precision, and scientific integrity.
Additional drug-drug interaction (DDI) assays: