Log in
Register|
ioanam ★ Romania, 2012-08-19 10:54 (5047 d 17:28 ago) Posting: # 9080 Views: 4,349 |
|
|
Dear all, I need your opinion in a problem concerning intra-subject variability. as Sponsor, we received the results of a full - replicated study and I have found something interesting in the statistical report. The CRO reported also the values obtained for intra- subject variability for test and also for reference product. But the reported value is identical with Geo CV of mean Cmax for the tested products. More than that, these values are almost double compared to those reported for reference in literature. Is this possible? Thank you. Regards, Jo |
|
Helmut ★★★   Vienna, Austria, 2012-08-20 01:57 (5047 d 02:25 ago) @ ioanam Posting: # 9083 Views: 3,537 |
|
|
Hi Ioana! ❝ The CRO reported also the values obtained for intra- subject variability for test and also for reference product. The former is nice to know and only the latter needed for scaling. ❝ But the reported value is identical with Geo CV of mean Cmax for the tested products. That’s a crude estimate of CVtotal. Its value could only be identical to CVintra if CVinter = 0… I guess the CRO screwed up. ❝ More than that, these values are almost double compared to those reported for reference in literature. Unlikely, but not impossible. Comparisons (especially of HVDs/HVDPs) between study are always problematic. BTW, do you trust in their bioanalytics? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
ioanam ★ Romania, 2012-08-21 10:55 (5045 d 17:27 ago) @ Helmut Posting: # 9088 Views: 3,446 |
|
|
Thank you for response Helmut  I needed to see a similar point of view with what I was thinking. The CRO will be audited again, to review the whole study.  Regards Jo |
Ing. Helmut Schütz