Clarity on waiving multiple dose study [Regulatives / Guidelines]

posted by Tina – India, 2013-05-15 16:19 (3849 d 14:05 ago) – Posting: # 10585
Views: 20,396

Dear all,

The recently updated MR guideline (EMA/CPMP/EWP/280/96 Corr1) mentions about the possibility of waiving multiple dose study (593-595). However, 612-615 mentions that there isnt sufficient scientific evidence. With the current scenario, would waiving multiple dose study on the basis suggested in 593-595 be a risk? How can a generic company justify scientific evidence for this approach?


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.


The discussion of the opportunity of using equivalence in Cτ in single dose studies as basis for waiving the multiple dose study has been recognized. However, there is not considered to be sufficient scientific evidence at the moment to encourage this approach.

Thank the team in advance for clarification.

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