For a prompt and seamless IND approval

The line of services entitled IND Enabler refers to the full-size, GLP-compliant cardiac toxicity assessment assays mentioned in the ICH guidelines S7A and S7B. Included in IND Enabler are the hERG inhibition assay, considered to be a necessary complement to the in-vivo assessment of QT prolongation in telemetered animals, as well as action potential duration measurements and analysis, and ionic current inhibition assays, both of which are labeled as complementary assays in the ICH guidance documents.

The IND enabler assays are designed to generate reliable and unambiguous results which will confirm the absence of cardiac liability for a given compound, or alternatively, provide a clear indication of those conditions under which the compound may exhibit cardiac toxicity.  In addition, it is considered an invaluable tool for assembling a convincing cardiovascular profile for your IND application.


  • hERGGLP
    Full-size rapid delayed rectifying potassium (IKr) current inhibition assay using manual whole-cell patch clamp technique
    Protocol outline:
    • TA tested on seven (7) HEK 293 cells stably transfected with the hERG gene at four (4) rising concentrations.
    • E-4031 as positive control, IC50 determination
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  • APDGLP
    Full-size Action Potential Duration analysis on purkinje fibres or contractile cardiac tissues from small animals, large animals and human donor hearts
    Protocol outline:
    • TA tested on five (5) tissues and at 4 rising concentrations
    • E-4031 as positive control
    • Amplitude of the action potential, rate of depolarisation, APD30, 60, 90 determination
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  • In-Vivo/In-Vitro QTGLP
    Full-size pre-IND study package including manual hERGGLP & in-vivo ECG in small animal
    Protocol outline:
    • Manual hERGGLP:
    • In-vivo ECG and arterial blood pressure in conscious and surgically instrumented
      animals, with suitable DSI telemetry monitoring
    • Cisapride, dofetilide or E-4031 as positive control
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  • E-C couplingGLP
    Simultaneous APD and contraction measurements on contractile cardiac tissues from small animals, large animals and human donor hearts
    Protocol outline:
    • TA tested in 3 tissues at 3 concentrations
    • Cisapride, dofetilide or E-4031 as positive control
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