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Table 4 Simulation of 1000 bioequivalence trials

From: Bioequivalence clinical trial simulation: a case study of apalutamide administered in applesauce versus whole tablets

No. of subjects per BE trial (N)

Single dose

Multiple dose (steady state)

No. of trials met BE (out of 1000)

POS (%)

No. of trials met BE (out of 1000)

POS (%)

10

11

1.1

860

86.0

20

2

0.2

977

97.7

30

1

0.1

995

99.5

40

0

0

1000

100

  1. AUC Area under the concentration–time curve, BE Bioequivalence, Cmax Maximum plasma concentration, POS Probability of success in demonstrating bioequivalence for both Cmax and AUC in 1000 simulated trials
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