Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Missing concentration [Study Assessment]

posted by shahajan baig – India, 2020-07-06 01:15 (107 d 07:31 ago) – Posting: # 21651
Views: 754

Hello everyone,

I have one question with respect to missing sample concentration consider:

Case study:

One subject sample analysis for PK study did not shown any concentration in both the periods.
Dosing was done as per protocol compliance and same was monitored by CRO QA, QC and sponsor monitor and have documented for compliance done.
What could be a point of investigation for the above case????

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

—
Regards,

SHAHAJAN BAIG

Complete thread:

Missing concentrationshahajan baig 2020-07-06 01:15 [Study Assessment]
- Missing concentration Sukalpa Biswas 2020-07-13 13:51

Admin contact
21,170 posts in 4,411 threads, 1,474 registered users;
online 2 (0 registered, 2 guests [including 1 identified bots]).
Forum time: Wednesday 08:47 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences… Edgar Allan Poe

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz

Bioequivalence and Bioavailability Forum

Missing concentration [Study As­sess­ment]

Complete thread:

Missing concentration [Study Assessment]