Pharmaceutical Development: ICH Q8/Q(8)R
Pharmaceutical Development: ICH Q8/Q(8)R
Pharmaceutical Development: ICH Q8/Q(8)R
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Design Spaces Example #2<br />
Dissolution<br />
2<br />
1.8<br />
Design space for multiple attributes<br />
Dissolution<br />
Design<br />
Space<br />
0<br />
40 42 44 46 48 50 52 54 56 58 60<br />
Parameter 1<br />
Friability<br />
1.6<br />
1.4<br />
1.2<br />
1<br />
0.8<br />
0.6<br />
0.4<br />
0.2<br />
Parameter 2<br />
Dissolution (%)<br />
90.0-95.0<br />
85.0-90.0<br />
80.0-85.0<br />
75.0-80.0<br />
70.0-75.0<br />
65.0-70.0<br />
60.0-65.0<br />
Parameter 2<br />
2.0<br />
1.0<br />
Combined<br />
Design<br />
Space<br />
2<br />
Friability<br />
Design<br />
Space<br />
1<br />
Parameter 2<br />
Friability (%)<br />
4.0-5.0<br />
3.0-4.0<br />
2.0-3.0<br />
1.0-2.0<br />
0.0-1.0<br />
0.0<br />
40 50 60<br />
Parameter 1<br />
0<br />
40 50 60<br />
Parameter 1<br />
22
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