Investigational
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Verification/falsification of structural alerts<br />
NOVARTIS<br />
Toxicology will perform Ames test (or other suitable test as indicated<br />
by structural alert)<br />
‣ Why primarily the Ames test?: it detects with greatest reliability DNA reactive<br />
compounds (or metabolites of them)<br />
‣ Most DNA reactive compounds are multi-organ carcinogens<br />
‣ Few false positives in the Ames test (Ames positive non-carcinogens)<br />
‣ Few toxins are known that are DNA reactive in mammalian cells but not in<br />
bacteria<br />
(<br />
Test(s) confirm in-silico hypothesis?<br />
If no, then no special limits, no special testing<br />
If yes, acceptable limits proposed adapted to the phase of the clinical<br />
program<br />
! Important: chemical expert reasonning can be an alternative to<br />
testing (and limit setting) especially in early phases of development !<br />
L. Müller, Swissmedic, 21-Oct-2003
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