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URL: http://iccvam.niehs.nih.gov/methods/invidocs/guidance/iv_guide.htm.
The RC Prediction Model allows a validated cytotoxicity assay to be used to convert inhibitory concentrations (IC values) into in vivo relevant doses for animal studies. In our Toxicological Sciences article, we have gone one step further and demonstrated that when HALO® is used with fresh human target cells, the IC results can be converted to human dosing values in mg/kg or mg/m2. For the drugs tested, almost all produced comparable values to those that are actually being used today in anti-cancer clinical therapy. As far as we are aware, no other in vitro assay system has been taken to this extreme and demonstrated that it can predict dosing for human clinical trials.
It is for this reason why we can call the HALO® Platform a true Predictive Hemotoxicity Assay and why it should be used at the earliest possible stage in drug discovery and development.
To be able to use HALO® for Predictive Hemotoxicology, we have developed several specialized assays that allow a "global" view of the lympho-hematopoietic system to be assessed and to determine potential residual drug damage and change in drug sensitivity to multiple administrations. Our goal is to provide you, the user, with the best possible tools to determine lympho-hemotoxicity. As such, we are continually striving to produce new, validated assays.
The latest predictive hemotoxicity platform to be developed by HemoGenix® is HALO®-DDI (Drug-Drug Interaction). This powerful, cell-based is used to study the effect of combining two or more compounds on the response of the cells of the lympho-hematopoietic system.