ORGLIST: on testing of gemptoxicity, Ames test

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From: Younan Shih-史又南 (Younan.Shih$##$scinopharm.com.tw)
Date: Sun Apr 13 2008 - 12:17:02 EDT


Dear all,

Since 2007, especially European regulatory authorities are very concern about “genotoxic impurities”, GTI, in the drug substance. Ames test is commonly used screen if the chemical has genotoxicity. Do you perform this test in your lab or contract out? Is there any specific protocols to follow?

How long will it take for one Ames test?

Can anyone share your experience?

Thanks everyone

 

Younan Shih

 


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