EMA: AUC72 for all IR products [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2020-06-24 10:47  – Posting: # 21571
Views: 725

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.

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