necessity of retention samples for pilot BE study [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-11-25 17:38  – Posting: # 20867
Views: 231

It is a great question,

thanks Shuanghe for asking it.



» According to FDA's guidance (21CRF), sufficient retention samples (5 times complete analysis or 300 units etc ) should be kept in CRO where the BE studies were conducted. The guidance doesn't mention if this is for pilot or pivotal. Obviously, you need this for pivotal BE, but what about pilot BE?

I have been wondering something along exactly the same lines recently.

My angle on this was related. FDA recently issued a PSG for Beclo/Calcipotriol introducing the need for a pilot trial.
The idea to have a pilot trial relates to a guidance which is roughly 16 bilion years old but which still stands.

It is not clear, given exactly the wording quoted by Ohlbe what status to give to the pilot. On one hand the pilot does not give pivotall proof of BE, on the other hand it does seem required when you read the PSG. One can of course go into the semantics and discussion the practical meaning of "required" and "recommended" etc. I will abstain from doing so - my experience with such discussion is not so good. To me, if it is in a FDA BE guidance (PSG or not, draft or not) to do X, Y and Z, then I do X, Y and Z without shortcuts unless I have a tremendously good reason from FDA not do to do so. Opinions on X, Y and Z from any entity which is not FDA will on those matters be less important for the decision-making.

So it does create an unclear situation. I'd do full retention, switch CRO if necessary in the absence of a controlled correspondence or FDA communication to the opposite.

In perspective: Is the Beclo/Calcip guidance the first one mentioning the need (or whatever it is) for a pilot?

I could be wrong, but...
Best regards,
ElMaestro

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