D 75N95022Q00438-QuestionsandResponses_Amendment 2.pdf
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- Testing of compounds in CYP inhibition, hERG inhibition, PPB, and Caco-2 permeability assays
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- 75N95022Q00438
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COMBINED SYNOPSIS / SOLICITATION
75N95022Q00438
TITLE: Testing of compounds in CYP inhibition, hERG inhibition, PPB, and Caco-2 permeability assays
No. Vendor Question Government Response 1 Task 1: Test ten (10) compounds in four CYP450 Inhibition Assays. Only the following three are mentioned, CYP3A4 (midazolam substrate), CYP2C9,and CYP2D6.
This is a typo. There are three (3) CYP450 inhibition assays: CYP3A4 (midazolam substrate), CYP2C9,and CYP2D6.
The Statement of Work has been corrected accordingly.
2 For tasks 2, 3 and 4, do you have an idea of the batch sizes?
Single batch size of 10. Tasks should be independent. (ie, Task 2 can be sent separately from Task 3).
3 For task 4, will it be human or other species?
Other species (mouse)
4 For task 2, is it acceptable to test the compounds at more than 3 different concentrations?
Yes, it is acceptable. The Statement of Work has been revised to require the compounds to be tested at “at least 3” different concentrations.
END
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