Applications of IVIVC in Formulation Development - PQRI
Applications of IVIVC in Formulation Development - PQRI
Applications of IVIVC in Formulation Development - PQRI
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Evaluation <strong>of</strong> Dissolution Specifications<br />
Time Po<strong>in</strong>t<br />
Statistical Limits –<br />
Statistical Limits –<br />
Pass<strong>in</strong>g L1 Pass<strong>in</strong>g L1<br />
95% Chance <strong>of</strong> 99% Chance <strong>of</strong><br />
Limits Based<br />
on <strong>IVIVC</strong><br />
2 hours NMT 33% NMT 34% 17 – 37%<br />
4 hours 33 – 50% 32 – 51% 32 – 52%<br />
8 hours 50 – 73% 50 – 75% 52 – 72%<br />
12 hours 63 – 95% 63 – 95% 69 – 89%<br />
24 hours NLT 83% NLT 82% NLT 87%
Change language