## power.TOST.sim and uncertainty [Outliers]

❝ Lets say I plan study with theta0=0.95, CV=0.20, design="2x2", targetpower=0.8 (all except CV are default settings in PowerTOST), so with sampleN.TOST I get N=20 and power=0.834680

❝ `> sampleN.TOST(theta0=0.95, CV=0.20, design="2x2", targetpower=0.8, print=FALSE)`

```
❝ Design alpha CV theta0 theta1 theta2 Sample size Achieved power Target power
```

❝ 2x2 0.05 0.2 0.95 0.8 1.25 20 0.8346802 0.8

❝

❝ If all of my assumptions in a study are exactly realized, doesnt it mean that I would 100% always get bioequivalent formulations (and the study would never fail)?

❝ If all of my assumptions in a study are exactly realized (pe=0.95, CV=0.20, design="2x2", n=20) then I would get the following confidence interval:

❝ `> CI.BE(pe=0.95,CV=0.20,n=20)`

```
❝ lower upper
```

`❝ 0.8522362 1.0589787 `

I think

*exactly realized*means a bit different thing.

Take a look at

`power.TOST.sim()`

function in PowerTOST packageThe description says:

`Power is calculated by simulations of studies (PE via its normal distribution, MSE via its associated χ2 distribution) and application of the two one-sided t-tests. Power is obtained via ratio of studies found BE to the number of simulated studies.`

So

*exactly realized*means that the variance and centers of distributions used in power estimation were close to the true values, nothing more.

`> power.TOST.sim(n = 20, CV = 0.2, theta0 = 0.95, nsims = 1000)`

[1] 0.832

# easy to find non-BE replicate

> set.seed(5)

> power.TOST.sim(n = 20, CV = 0.2, theta0 = 0.95, nsims = 1, setseed = FALSE)

[1] 0

Kind regards,

Mittyri

### Complete thread:

- Outlier in fully replicate BE study Loky do 2021-06-16 00:49 [Outliers]
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
- Widening for clopidogrel BE study Loky do 2021-06-16 15:38
- Widening for clopidogrel BE study mittyri 2021-06-16 16:04
- Widening for clopidogrel BE study Loky do 2021-06-16 17:08
- Widening for clopidogrel BE study - cherry-picking? mittyri 2021-06-16 17:27
- Widening for clopidogrel BE study drgunasakaran1 2021-06-17 12:01
- Hypotheses Helmut 2021-06-19 12:32
- Hypotheses Loky do 2021-07-06 11:51
- ABEL ≠ RSABE Helmut 2021-07-06 16:17
- ABEL ≠ RSABE BEQool 2023-10-09 14:47
- power.TOST.sim and uncertaintymittyri 2023-10-11 12:42
- power.TOST.sim and uncertainty BEQool 2023-10-15 11:29
- power.TOST.sim and uncertainty mittyri 2023-10-20 21:47
- Distribution of PEs Helmut 2023-10-23 10:48
- Distribution of PEs BEQool 2023-10-23 19:55
- power.TOST.sim code mittyri 2023-10-31 15:40
- power.TOST.sim code BEQool 2023-11-02 11:22

- power.TOST.sim code mittyri 2023-10-31 15:40

- Distribution of PEs BEQool 2023-10-23 19:55

- Distribution of PEs Helmut 2023-10-23 10:48

- power.TOST.sim and uncertainty mittyri 2023-10-20 21:47

- power.TOST.sim and uncertainty BEQool 2023-10-15 11:29

- power.TOST.sim and uncertaintymittyri 2023-10-11 12:42

- ABEL ≠ RSABE BEQool 2023-10-09 14:47

- ABEL ≠ RSABE Helmut 2021-07-06 16:17

- Hypotheses Loky do 2021-07-06 11:51

- Widening for clopidogrel BE study Loky do 2021-06-16 17:08

- Widening for clopidogrel BE study mittyri 2021-06-16 16:04

- Widening for clopidogrel BE study Loky do 2021-06-16 15:38

- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59