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GLP – assays required for IND submission:
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GLP hERG IC50 – tightest IC50s ever published (Kirsch et al. J Pharm Tox Method 2004)
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GLP Dose Solution Analysis – our synchronized process identifies compound stability issues
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GLP – recommended repolarization/follow-up assays:
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GLP APD Purkinje fiber assay with time-matched vehicle controls for rundown & stability (canine & rabbit available) – Identifies which channels are affecting the action potential duration (mixed ion channel effects)
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GLP CT-QT isolated heart assay measuring QT, contractility, MAPD, & other parameters with time-matched vehicle controls for rundown & stability (isolated rabbit heart) – Evaluates mixed ion channel effects & provides a comprehensive assessment of the effects of drugs on cardiac activity
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GLP Dose Solution Analysis – our synchronized process identifies compound stability issues
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GLP Cardiac Channel PanelTM (auto-patch) or manual patch clamp cardiac channel IC50 counter screen – identifies the cardiac ion channels that determine repolarization risk
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Non-GLP – basic ion channel profiling screens:
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Manual patch clamp screen (1-2 concentration screen for each compound) – tabular results, ranked to identify the safety of drug candidates
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FASTPatch automated patch screen (1-2 concentration screen for each compound) – tabular results, ranked to identify the safety of drug candidates
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Manual patch clamp IC50 screen (concentration-response curve & IC50 3+ concentration screen for each compound) – determines the safety of therapeutic doses of drug candidates
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Non-GLP – additional hERG screens:
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HERG-Lite screen – economically identifies hidden hERG trafficking inhibition
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FAST & LiteTM (FASTPatch® & HERGLite®) – Provides a comprehensive valuation of hERG inhibition – both direct block & defective trafficking
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Non-GLP – repolarization or follow-up screens:
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APD Purkinje fiber assay with time-matched vehicle controls for rundown & stability (canine & rabbit available) – Identifies which channels are affecting the action potential duration (mixed ion channel effects)
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CT-QT isolated heart assay measuring QT, contractility, MAPD, & other parameters with time-matched vehicle controls for rundown & stability (isolated rabbit heart) – Evaluates mixed ion channel effects & provides a comprehensive assessment of the effects of drugs on cardiac activity
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Cardiac Channel PanelTM (auto-patch) or manual patch clamp cardiac channel IC50 counter screen – identifies the cardiac ion channels that determine repolarization risk
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Non-GLP – other assays
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S7A Channel Profiling PanelTM – FDA Critical Path tools for predicting safety & efficacy
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