Bioequivalence and Bioavailability Forum

ULOQ [Study Assessment]

posted by Anand – India, 2017-10-30 07:38 (2362 d 22:59 ago) – Posting: # 17945
Views: 9,210

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]

Complete thread:

ULOQAnand 2017-10-30 06:38 [Study Assessment]
- ULOQ Helmut 2017-10-30 10:30
- ULOQ Ohlbe 2017-10-30 10:35
  - ULOQ Helmut 2017-10-30 10:59
    - ULOQ Ohlbe 2017-10-30 15:10
      - Not excluding invalid data? Helmut 2017-10-30 17:34
        
        Excluding invalid data Ohlbe 2017-10-30 18:03
- ULOQ ElMaestro 2017-10-30 13:18
  - Serial dilutions? Don’t! Helmut 2017-10-30 17:53

ULOQ [Study As­sess­ment]

Complete thread:

ULOQ [Study Assessment]