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ICEADR™ Carcinogenic Risk Safety Panel

A mechanism-informed secondary pharmacology panel designed to generate compound-specific evidence for carcinogenic risk assessment within an integrated Weight of Evidence strategy.

Scientific Background
Carcinogenicity Assessment in Drug Development

Learn which pharmaceuticals may require carcinogenicity studies, what ICH S1B(R1) changed, and how secondary pharmacology contributes to an integrated Weight of Evidence assessment.

Product Overview

Generate Early Evidence for a More Informed Carcinogenic Risk Assessment

ICEADR™ comprises 40 targets and 68 functional assays selected to evaluate pharmacological activities with potential relevance to carcinogenic risk. The panel supports assessment of both parent compounds and major metabolites and is designed with reference to the ICH S1B(R1) Weight of Evidence framework.

40

Mechanistically Relevant Targets

Targets selected across multiple biological mechanisms associated with potential carcinogenic liability.

68

Functional Assays

Functional formats designed to characterize activation, inhibition, agonism, antagonism, or pathway-level effects.

Flexible Testing Formats

Available as either single-concentration screening or concentration–response characterization.

ICH S1B(R1)-Informed Strategy

Supporting Secondary Pharmacology Evidence Within a Weight of Evidence Framework

ICH S1B(R1) identifies secondary pharmacology data for the parent compound and major human metabolites as one of the principal evidence streams used to inform compound selectivity, off-target potential, and carcinogenic risk. ICEADR™ is designed to support this evidence-generation need through focused functional assessment of targets with mechanistic relevance to carcinogenesis.

Target Class Coverage

Focused Coverage of Pharmacological Systems Relevant to Carcinogenic Risk

The panel places particular emphasis on nuclear receptors, GPCRs, and enzyme targets, while extending coverage to additional pathways associated with epigenetic regulation, inflammation, immune modulation, cellular injury, and genotoxic stress.

GPCR Targets

17

Evaluation of receptor-mediated pathways relevant to endocrine balance, immune signaling, tissue responses, and long-term pharmacological modulation.

Enzyme Targets

7

Functional testing of enzymes associated with epigenetic regulation, inflammatory pathways, immune responses, cellular injury, and genotoxic mechanisms.

Kinase Targets

3

Kinase targets are evaluated under a 1 mM ATP condition to support functional assessment in a more physiologically relevant biochemical environment.

Nuclear Receptors

13

Functional assessment of receptor systems associated with hormonal regulation, steroid signaling, metabolic control, and proliferative responses.

Multi-Mechanism Risk Coverage

From Target Selectivity to Cancer-Relevant Biological Mechanisms

ICEADR™ extends beyond a general-purpose safety panel by including targets linked to multiple biological mechanisms that may contribute to carcinogenic risk.

Epigenetic Regulation
Inflammation
Immune Modulation
Cellular Injury
Genotoxic Stress
Hormonal Signaling
Cell Growth & Survival
Tissue Remodeling
Scientific Interpretation

ICEADR™ is not intended to independently classify a compound as carcinogenic or non-carcinogenic, nor to replace genotoxicity testing, repeated-dose toxicology, or dedicated regulatory carcinogenicity studies. The panel provides a compound-specific secondary pharmacology evidence stream that can contribute to an integrated assessment of human carcinogenic risk.


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