ULOQ [Study As­sess­ment]

posted by Anand – India, 2017-10-30 06:38  – Posting: # 17945
Views: 5,938

Dear All,

Request to clarify,

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

Thanks in advance.

Regards,
A.A


Edit: Category changed; see also this post #1. [Helmut]

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