Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
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<strong>Pharmacokinetic</strong> <strong>and</strong> <strong>Statistical</strong> <strong>Analysis</strong> <strong>of</strong> <strong>BE</strong> <strong>Data</strong><br />
HVDPs (EMA/FDA; sample sizes)<br />
RTRT | TRTR, 80% power, EMA<br />
sample<br />
size<br />
RTRT | TRTR, 80% power, FDA<br />
sample<br />
size<br />
100<br />
360<br />
100<br />
360<br />
336<br />
336<br />
CV%<br />
90<br />
80<br />
70<br />
60<br />
168<br />
120<br />
96<br />
72<br />
48<br />
36<br />
96<br />
72<br />
144<br />
120<br />
312<br />
288<br />
264<br />
240<br />
216<br />
192<br />
168<br />
144<br />
CV%<br />
90<br />
80<br />
70<br />
60<br />
168<br />
96<br />
72<br />
48<br />
36<br />
24<br />
36<br />
48<br />
96<br />
72<br />
120<br />
216<br />
312<br />
288<br />
264<br />
240<br />
216<br />
192<br />
168<br />
144<br />
50<br />
24<br />
120<br />
96<br />
50<br />
120<br />
96<br />
40<br />
30<br />
120<br />
0.85 0.90 0.95 1.00 1.05 1.10 1.15 1.20<br />
96<br />
72<br />
48<br />
36<br />
24<br />
12<br />
40<br />
30<br />
96<br />
0.85 0.90 0.95 1.00 1.05 1.10 1.15 1.20<br />
72<br />
48<br />
36<br />
24<br />
12<br />
GMR<br />
GMR<br />
1 st MENA Regulatory Conference on Bioequivalence, Biowaivers,<br />
Bioanalysis <strong>and</strong> Dissolution | Amman, 23 – 24 September 2013<br />
41 • 50
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