BE assessment regarding first time point Cmax [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2018-12-28 14:32 (792 d 02:00 ago) – Posting: # 19718
Views: 5,167

Hello Erkin,

» If these early samples were not collected, then those subjects with first point Cmax values should be dropped from the primary statistical analysis.
» I couldn't find the reference from EMA or FDA about dropping the subjects. I've contacted to Dr. Leon Shargel via e-mail and asked him the same question.

The whole business of dropping certain subjects, disregarding data, and getting rid of some data data while keeping other data is a discipline in which many companies, CROs and applicants are extremely skilled but not overly successful when facing regulators. If the guideline does not mention the opportunity to drop subjects data in accordance with your decision scheme then perhaps that is because regulators don't want you to drop data that way? Just thinking of this as a remote hypothetical possibility.

Funnily enough, perhaps it is just me hallucinating: Sometimes I get the impression that when CROs and Sponsors try and enter these discussions about getting rid of certain data in ways not stipulated by a protocol it seems always to be about getting rid of data that is unwanted for the purpose of showing BE, and much effort is put into keeping just the data the result in demonstration of BE. Isn't that really, really strange....?

Pass or fail!

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