Analysis in a group dosing study [Bioanalytics]

posted by Smitha – India, 2015-07-09 09:48 (3502 d 20:44 ago) – Posting: # 15057
Views: 4,724

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

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,665 registered users;
152 visitors (0 registered, 152 guests [including 5 identified bots]).
Forum time: 05:33 CET (Europe/Vienna)

There are sadistic scientists who hurry to hunt down errors
instead of establishing the truth.    Marie Curie

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5