Smitha
☆    

India,
2015-07-09 09:48
(3185 d 06:52 ago)

Posting: # 15057
Views: 4,160
 

 Analysis in a group dosing study [Bioanalytics]

Dear all,
We are planning to conduct a FDA submission study in 3 groups (due to logistic limitations).

My query was on the analysis of the subjects in the Bioanalytical Lab.

Is it acceptable that the bioanalysis of Group 1 subjects (Periods 1 and 2) be initiated before the dosing of Group 2 and Group 3 subjects?

The randomization schedule is tightly controlled with no access to the Analysts and the subject concentrations will not be shared with the Clinical unit.

Would appreciate the opinion of the forum members on the acceptability of this plan and any thoughts to the contrary.


Regards,
Smitha
Smitha
☆    

India,
2015-07-13 08:52
(3181 d 07:48 ago)

@ Smitha
Posting: # 15072
Views: 3,314
 

 Analysis in a group dosing study

Dear all,
Would appreciate it if any of the forum members would respond :-)

Regards,
Smitha


Edit: Four day ≠ two weeks. See the Forum’s Policy. We are posting in our spare time. If you want a quick answer, higher a consultant. [Helmut]
jag009
★★★

NJ,
2015-07-22 18:23
(3171 d 22:17 ago)

@ Smitha
Posting: # 15127
Views: 3,151
 

 Analysis in a group dosing study

Hi,

❝ We are planning to conduct a FDA submission study in 3 groups (due to logistic limitations).


Is this a parallel study or a crossover study with groups?

You have a timeline issue? If not, I would prefer to finish all dosing and PK samplings before starting bioanalytical.

John
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