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RegisterAnalysis 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
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
Complete thread:
- Analysis in a group dosing studySmitha 2015-07-09 07:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Analysis in a group dosing study Smitha 2015-07-13 06:52
- Analysis in a group dosing study jag009 2015-07-22 16:23
Ing. Helmut Schütz