## Why BE testing use 90 CI [General Statistics]

Hi Akash,

» Why Bioequivalence testing makes use of the 90 CI why not 95 CI which gives more accuracy?

More accuracy, what does that mean?

We have some more or less empirically justified limits of 80.00%-125.00%.

And we want a 5% risk of making the wrong conclusions in the sense of regulatory (patient's) risk; in practice this means we adopt a policy of a 5% risk of approving a product that is not BE. This is where the 90% CI comes into the equation. There is a (not more than) 5% risk associated with it (1-2*alpha).

A 95% CI would be less risky, ie. up to 2.5% chance of approving a non-BE product. Why would we want that, then alpha=5% seems to work just fine?

» Why Bioequivalence testing makes use of the 90 CI why not 95 CI which gives more accuracy?

More accuracy, what does that mean?

We have some more or less empirically justified limits of 80.00%-125.00%.

And we want a 5% risk of making the wrong conclusions in the sense of regulatory (patient's) risk; in practice this means we adopt a policy of a 5% risk of approving a product that is not BE. This is where the 90% CI comes into the equation. There is a (not more than) 5% risk associated with it (1-2*alpha).

A 95% CI would be less risky, ie. up to 2.5% chance of approving a non-BE product. Why would we want that, then alpha=5% seems to work just fine?

—

I could be wrong, but...

Best regards,

ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

I could be wrong, but...

Best regards,

ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

### Complete thread:

- Why BE testing use 90 CI akash 2019-02-23 08:39 [General Statistics]
- Why BE testing use 90 CIElMaestro 2019-02-23 10:18
- Why BE testing use 90 CI Ohlbe 2019-03-03 23:07
- one-sided / two-sided Helmut 2019-03-04 01:20
- one-sided / two-sided ElMaestro 2019-03-04 09:04
- one-sided / two-sided Helmut 2019-03-04 11:25

- one-sided / two-sided ElMaestro 2019-03-04 09:04

- one-sided / two-sided Helmut 2019-03-04 01:20

- Why BE testing use 90 CI Ohlbe 2019-03-03 23:07

- Why BE testing use 90 CIElMaestro 2019-02-23 10:18