Posting style & incomplete information [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2013-07-28 14:32 (4306 d 16:11 ago) – Posting: # 11083
Views: 20,688

Hi Sam!

❝ 1. […] we have carried out Fed studies before the Fasting study.


Oops, I overlooked the order of studies. Sometimes that happens (I didn’t say that products in fed state always perform worse than in fasting state). If I recall it correctly Dan reported another case a while ago.

❝ 3. But totally depressed by seeming the results of the Fasting Data.


No need to be depressed. Get paroxetine or visit your vegetarian and ask for Schützo­mycin. Once again: One out of five studies fail on pure chance. Make it your Mantra. Suggest it to your boss as well.

❝ But as you stated that the chances of variation is more in the Fed compared to the Fasting study.


Chances! Rules of thumb ≠ laws. This information comes from my personal experience of 600+ BE studies.

❝ That’s why the questions comes out in our mind that there may be some flaws in the study conduct of the Fasting study.


Did you monitor the study? Any observations? If not, audit the CRO. Without nailing down a root cause it will not be ethical to repeat the study in another CRO – only “justi­­fied” because you did not like the study’s outcome (murmur the Mantra instead).

❝ If we are talking about the formulation problem then why the same is not reflecting in the Fed study.


I don’t practice reading tea leaves. You should know the formulation best.

❝ Few of the results are also provided for your references and give us the final suggestions.


Why only a few? BTW, it took me ten minutes to edit your post (tabulators are rendered to single spaces in HTML). Please read the Forum’s “Operating Instructions”, go and play around in the Sandbox-category, and always (!) use the [image] before posting. It’s intentional that this button is the first one in the row.
Thank you very much in advance.

In the future please give results in percent to two decimals (as required by FDA & EMA) or with five significant figures. Why do you think we deserve less information than regulators?

I still miss the sample sizes. It seems that the fasting pilot was performed in fifteen sub­jects. For the fed pivotal I guess you evaluated 49 (Cmax), 48 (AUCt), and 36 (AUC∞). For the fasting pivotal I guess 56 for both AUCs and 60 for Cmax. Why did you exclude subjects – especially from the comparison of AUCt?

Are the headings of the tables correct? Which was the outcome of the fed pilot?

Please [image] your original post until Monday 12:35 IST. The output looks winnonlinish to me. Post hoc power is
  1. meaningless (see my last post) and
  2. flawed in WinNonlin for ages and in Phoenix as well (see this thread).
    This column offends my eye.
You want some help? Fine. In the future give us all information you have already in the first post.* This question-and-answer-to-and-fro-game (aka worm information out of you) is wasting our time. Example: From the different sample sizes of metrics in the same studies I suspect problems with the profiles. Don’t you consider it worthwhile answering John’s post?

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