Challenges related to safety concerns in drug development persist as a significant hurdle for the pharmaceutical sector. Safety Pharmacology, as outlined by ICH S7A (2001), places a critical emphasis on the evaluation of drugs for off-target effects. In vitro Pharmacological profiling is now more frequently employed at the initial stages of drug discovery to detect unfavorable off-target activity profiles. These profiles, if identified post-approval, have the potential to impede candidate drug development or, in some cases, prompt market withdrawal. In vitro Pharmacological profiling now plays a vital role in scrutinizing how drug candidates interact with molecular targets distinct from their intended therapeutic targets.
The theoretical foundation for these services is based on the publication "Reducing safety-related drug attrition: The use of in vitro pharmacological profiling" from Nature Reviews Drug Discovery. This publication highlights the importance of early identification of off-target activities to reduce late-stage attrition in drug development.
Early Profiling Benefits: Early identification of off-target interactions can prevent the development of drug candidates that may later fail due to safety issues.
Predictive Power: In vitro pharmacological profiling can predict ADRs that might not be evident in traditional in vivo studies or early clinical trials.
Decision-Making: Early safety data can guide lead optimization and candidate selection, reducing the risk of late-stage failures.
Mechanistic Understanding: Profiling provides insights into the mechanisms underlying observed ADRs, facilitating better risk management.
Safety Margins: Data from profiling helps calculate safety margins, ensuring a better balance between efficacy and safety.
At ICE Bioscience, we've pioneered state-of-the-art functional safety panels. ICESTP™ SafetyOne44 is designed for 44 specific targets, while ICESTP™ SafetyMax90 stands as the most comprehensive functional safety panel available, encompassing up to 90 targets. We also provide specialized functional panels tailored to specific research areas, including CNS panels. Compared to binding assays, our functional assays offer the advantage of expertise in distinguishing between different modes of action.
These panels are used to study and assess how drugs interact with various molecular targets, including off-target interactions. This information is crucial for predicting and mitigating ADRs and ensuring the safety and efficacy of drug candidates during the drug development process.
Our ICESTP™ SafetyOne44 and ICESTP™ SafetyMax90 functional panels are designed to set new standards in safety pharmacology.
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ICE Bioscience leads in Safety Pharmacology services. Tailor your own panels to meet your specific drug discovery needs. Our experts and a vast portfolio of in vitro assays are at your service. Let us drive your drug discovery program forward.
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