Regulators truncated [NCA / SHAM]

posted by d_labes  – Berlin, Germany, 2009-06-18 09:26 (4429 d 17:38 ago) – Posting: # 3872
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Dear Ohlbe, dear Jaime, dear all,

let me share some experience with regulators in the EMEA. In a recent submission of a BE study with a long half-life product (t1/2 from literature about 50-70 h) we submitted an evaluation with AUC(0-72h), Cmax and tmax as metrics, the typical truncated area setting.

Regulators response:
The Germans asked for AUC(0-inf)!
The French asked for lamdaZ (kel) and t1/2!


Hopefully they will not ask for residual area <20% :angry: .

Regards,

Detlew

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