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Advantages of Using the TTC Concept<br />
NOVARTIS<br />
scientifically (databases) derived threshold<br />
(in contrast to the arbitrary use of uncertainty factors)<br />
conservative approach resulting in low ppm values<br />
can be applied even without preclinical data!<br />
will provide more consistency in controlling genotoxic<br />
impurities than case-by-case use of NOEL+UF-derived limits<br />
already accepted for regulatory purposes<br />
L. Müller, Swissmedic, 21-Oct-2003
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