Risking Refuse-to-Receive [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-03-28 11:25 (1071 d 14:32 ago) – Posting: # 18599
Views: 2,483

Hi sudy,

» […] can we use RSABE approach in case if we get ISCV-reference > 30% for any one of the PK parameter Cmax or partial AUCs, instead of using 90% CI calculation to prove the bioequivalence?

The guidance clearly states:

The 90% confidence intervals of the geometric mean test/reference (T/R) ratios for the above five Cmax and AUC metrics (Cmax, AUC0-T1, AUCT1-T2, AUCT2-T3, AUC0-∞) should fall within the limits of 80-125%.

Without a controlled correspondence you will risk an RTR because according to

» The OGD recommendation did not discuss anything about this case, as we know that methylphenidate is not a HVD.

In my experience you will get the highest CV in the first partial AUC of the fasting study. I never saw a high CV of Cmax… A CVwR >30% of AUC0-3 is extremely unlikely.

@John: Other experiences?

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Helmut Schütz

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