EMA: AUC72 for all IR products [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2020-06-24 08:47 (217 d 02:09 ago) – Posting: # 21571
Views: 1,164

Hi Loky do,

» For certain products, ema product-specific bioequivalence guidance states that the main PK variables: AUC0-72,...etc (also stated in the study protocol),

Not only the ones in product-specific guidances but all IR products (BE-GL page 9):

A sampling period longer than 72 h is therefore not considered necessary for any immediate release formulation irrespective of the half life of the drug.

» Is that mean any subject who miss 72 h will be excluded from AUC0-72 calculations?

No. If you have a reliable estimate of λz (at least three concentrations), you may use an estimate – if the exact method is stated in the protocol. E.g., in Phoenix/WinNonlin specify pAUC72 and you are fine. There are many posts in the forum discussing the details.

» if yes, there will be around 25% of subjects missed this interval, is that will be acceptable?

In principle yes but as an assessor I would question the clinical performance of the CRO.

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,316 posts in 4,446 threads, 1,489 registered users;
online 7 (1 registered, 6 guests [including 2 identified bots]).
Forum time: Wednesday 10:57 UTC (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz