Regulation of impurities in drug substances and products
Regulation of impurities in drug substances and products
Regulation of impurities in drug substances and products
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Q3B(R) Impurities <strong>in</strong> new <strong>drug</strong> <strong>products</strong><br />
(DP): Qualification, cont<strong>in</strong>ued<br />
“Degradation <strong>products</strong> could be<br />
considered qualified at levels higher than<br />
those adm<strong>in</strong>istered <strong>in</strong> safety y studies based<br />
on a comparison between actual doses<br />
given <strong>in</strong> safety studies <strong>and</strong> the <strong>in</strong>tended<br />
dose <strong>of</strong> the new DP.” --total dose <strong>of</strong><br />
iimpurity it given i i<strong>in</strong> safety f t study t d iis hi high h<br />
compared to total dose given cl<strong>in</strong>ically.<br />
Food <strong>and</strong> Drug Adm<strong>in</strong>istration
Change language