schedule time vs. actual time for AN­VI­SA BE [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2022-07-10 02:36 (147 d 12:06 ago) – Posting: # 23124
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Hi all,

I just had a wierd request from one of our clients regarding PK calculation in BE study intended to be submitted to ANVISA, and I'd like to know your experience with ANVISA in this regard. Detailed background below.

It's a pretty normal BE study of a solid oral drug product with systemic absorption, with a sentence in the protocol saying that PK parameters will be calculated with actual sampling time instead of scheduled time, which is pretty much universal standard these days.

Our client requested to change the protocol to say that PK will be calculated with scheduled time, not the actual time. Now that is an unusual request since I couldn't find such requirement in ANVISA's old (RDC 896, 2003) and new (RDC 1170, 2006) BE guideline, statistical guideline (RDC 898, 2003), and a few other guidelines that I thought might be remotely relevant.

When I requested the justification, I was told that this was their experince with ANVISA from deficient letters. It seems that if the protocol says using actual time for PK calculation the ANVISA will issue deficient letter requesting the scheduled time... I was told that our client had also asked some consultants and other companies in Brazil and they all had the similar experience...

For our study it really doesn't matter since we house the subject until the last PK sample is taken so the main expected time deviation would usually be a couple of minutes instead of possibly a few hours if ambulatory samles are involved and some subjects arrive late... But I really don't like the idea of writing such sentence in the protocol without justification from at least some regulatory guidelines...

What is your experience in this regard? My thought is that if this is a common request, someone would have had mentioned in the forum, but I couldn't find any post here ...

All the best,
Shuanghe

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