EMA: AUC72 for all IR products [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2020-06-24 12:47 (1768 d 23:04 ago) – Posting: # 21571
Views: 3,365

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
83 visitors (0 registered, 83 guests [including 3 identified bots]).
Forum time: 11:51 CEST (Europe/Vienna)

There are two possible outcomes: if the result confirms the
hypothesis, then you’ve made a measurement. If the result is
contrary to the hypothesis, then you’ve made a discovery.    Enrico Fermi

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5