HESI GTTC In Vivo Comet

HESI GTTC needs your help to improve the clarity and application of OECD TG 489 (In Vivo Mammalian Alkaline Comet) across most industries.  This survey is intended to help us focus our efforts by identifying the most critical issues and concerns of both industry and regulatory scientists.  If you have been considering, conducting, requesting, or reviewing regulated in vivo comet assay studies, please provide your input below.

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* 1. List your top 1-3 concerns or questions related to conducting, interpreting, or reviewing TG 489 comet studies. If you have not yet conducted or requested a comet study, include the issues that may have prevented or discouraged you from doing so.

You may include issues on any topic (e.g., study design, result interpretation) related to regulatory safety testing with the in vivo comet assay. But please provide any details and supporting information possible that will help us understand the scope and context of your concern or question. 

Examples of topics can include issues related but are not limited to:

Study design
·         Site of contact tissue concerns
·         Selecting the appropriate tissue(s) for evaluation

Sample collection/processing
·         Timing logistics
·         Controlling variability

Data interpretation / qualification
·         Cytotoxicity concerns
·         Use of historical control data

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* 2. What is your employment sector?

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* 3. What is your industry type? (e.g, consumer products, industrial chemicals, agri-chemicals, pharmaceuticals, cosmetics, medical devices, all of the above)

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* 4. What is your level of experience applying or reviewing TG 489 comet studies?

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