Bioequivalence and Bioavailability Forum

Still unclear… [General Statistics]

posted by Helmut – Vienna, Austria, 2013-08-27 17:07 (4333 d 16:16 ago) – Posting: # 11357
Views: 6,655

Hi Anu,

❝ I just need to know in FDA the accepted confidence intervals ranges are (80%-125%) & (-20% to +20%).

The acceptance range is 80.00–125.00% (90% CI in percent rounded to two decimals).

❝ I have a data for a reference product whose 90% CI is (-1.07% to -0.30%) on the CI scale of (-20% to +20%).

This doesn’t makes sense to me. Do you mean data for a test product (in % of the reference)?

❝ I want to transform it into the CI scale of (80%-125%).

❝ Can I do this?

Duno. I don’t believe in these numbers – where do they come from? In % of the reference the CI would be 98.93–99.70%. Assuming a 2×2 cross-over that would translate even for the smallest acceptable sample size of 12 into a CV of 0.52% [sic]. Simply impossible.

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Complete thread:

Confidence limits Anu 2013-08-26 07:15
- Confidence limits Dr_Dan 2013-08-26 11:05
  - Confidence limits Anu 2013-08-27 06:26
    - Still unclear…Helmut 2013-08-27 15:07
      - Is it still unclear :( ? Anu 2013-08-28 09:08
- Confidence limits jag009 2013-08-26 15:48
  - Confidence limits Anu 2013-08-27 06:28
    - Confidence limits ElMaestro 2013-08-27 06:47
      - Confidence limits Anu 2013-08-28 09:12

Still unclear… [General Sta­tis­tics]

Complete thread:

Still unclear… [General Statistics]