Bioequivalence and Bioavailability Forum • helter-skelter

helter-skelter [RSABE / ABEL]

posted by Mikalai – Belarus, 2020-02-10 17:10 (1708 d 14:56 ago) – Posting: # 21157
Views: 19,090
(edited on 2020-02-11 10:21)

Dear Helmut
There are some additional questions

❝ I cannot reproduce your numbers. Given.

My calculation was that I assumed that CV is 34 but we braced ourselves for the worst scenario. Am I correct that the worst scenario is around 42 subjects to compensate for TIE at CV 30% and 7(15%) subjects to compensate for a dropout rate?

PS
Total sample size 49

I assume that the TIE calculation is done after we have got our results from the sample. Is this calculation is straight forward with no other statistical approaches that may bring different results?

I guess that the TIE calculation and compensation for TIE correction were realized in PowerTost. What about validation issues? Any feedback from regulators on software?

How should we proceed if CV from our sample is 30.00%?

Should we calculate TIE if CV is less than 30% (I guess no)?

Has anyone submitted an ABEL trial with TIE correction and has got no objections from European regulators or FDA (Is this applicable for FDA?).

❝ Include the group term in the model (i.e., specify the FDA’s Model II taking into account that groups were tested on different dates) but without a pre-test. The loss in power is very, very low compared to the pooled Model III.

Can the use of Model 2 (FDA), basically group and its interactions, be a reason to reject study in Europe? Or it is a more conservative model and if we pass with this model we always pass with the standard ABE model?

Best regards

Complete thread:

Statistical evaluation and BE hypotheses in full replicate design Elena777 2020-01-28 07:02 [RSABE / ABEL]
- Inflation of the TIE as well Helmut 2020-01-29 15:38
  - Inflation of the TIE as well Elena777 2020-01-29 20:01
    - Tricky… Helmut 2020-01-30 12:07
      - Tricky… Mikalai 2020-01-30 13:08
        
        Terrible… Helmut 2020-01-30 15:09
        
        Tricky… Mikalai 2020-01-30 16:02
        
        Deep shit Helmut 2020-01-30 16:59
        
        Deep shit Mikalai 2020-01-30 18:39
        
        Deep shit Mikalai 2020-01-30 19:31
        Deep shit Helmut 2020-01-30 20:07
        
        Deep shit Mikalai 2020-01-31 11:14
        
        Deep shit Helmut 2020-01-31 14:00
        
        Deep shit Mikalai 2020-01-31 16:07
        
        Flawed evaluation accepted Helmut 2020-01-31 12:19
        
        Flawed evaluation accepted Mikalai 2020-01-31 12:40
        
        Flawed evaluation accepted Helmut 2020-01-31 14:17
        
        Flawed evaluation accepted Mikalai 2020-01-31 16:41
        
        Flawed approach even if accepted ? Helmut 2020-01-31 20:28
        
        Flawed approach even if accepted ? Mikalai 2020-02-01 16:18
        
        misunderstanding mittyri 2020-02-01 21:34
        
        misunderstanding Mikalai 2020-02-06 13:41
        
        misunderstanding mittyri 2020-02-06 16:23
        
        The globe is flat! d_labes 2020-02-05 19:16
      - Tricky… wienui 2020-01-30 18:53
        
        Tricky… Helmut 2020-01-30 19:18
        
        Tricky… wienui 2020-02-03 07:10
        
        ABE vs. ABEL Helmut 2020-02-03 12:25
        
        zigzag d_labes 2020-02-05 18:53
        
        zigzag Helmut 2020-02-05 19:46
        
        zigzag Mikalai 2020-02-06 11:38
        
        helter-skelter Helmut 2020-02-06 20:12
        
        helter-skelterMikalai 2020-02-10 16:10
  - Inflation of the TIE as well zizou 2020-02-01 17:00
    - Inflation of the TIE as well nobody 2020-02-01 23:30
  - Inflation of the TIE as well Elena777 2020-03-10 19:28
    - Fishing in the dark Helmut 2020-03-10 21:06
- Statistical evaluation and BE hypotheses in full replicate design nobody 2020-02-03 15:07
  - TIE, repeat once more please... Astea 2020-04-02 12:41