τ in SD = intended dosage interval [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2016-08-26 11:08 (1855 d 00:04 ago) – Posting: # 16581
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Hi BE-proff,

» Unless I am mistaken,

You are. ;-)

» … to comply with the statement you have cited we need to conduct steady state study anyway. Otherwise, how to get AUC0-tau? ;-)

The MR GL again, this time with the important part in red:

A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected.


Here τ is the intended dosage interval for the labeled posology. Say you want to dose b.i.d. (τ=12). In the SD study you will sample long enough to get a reliable estimate of λz (for the calculation of AUC0-∞). Now you have to show that AUC0–12 covers more than 90% of AUC0-∞ in order to waive the MD study.

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