ULOQ [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 11:30 (2810 d 07:12 ago) – Posting: # 17947
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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.

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