ULOQ [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 09:30  – Posting: # 17947
Views: 5,664

Hi Anand,

» In our Pivotal BE Study ULOQ was observed, whether we should exclude from PK?
» After Dilution also it found ULOQ.
» Method should be redeveloped or revalidated?

Perform a partial validation with a higher dilution. If passing the usual criteria for A&P, re-analyse the sample(s) with high concentrations.

» If included,What justification we should provide to Regulatory Agency?

IMHO, that’s not possible.

Cheers,
Helmut Schütz
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