Bioequivalence and Bioavailability Forum

dates in study plan of bioanalytical study [Bioanalytics]

posted by Ohlbe – France, 2013-03-18 19:35 (4454 d 13:26 ago) – Posting: # 10228
Views: 4,637

Dear Ken,

❝ Do you mean 3 dates are sufficient ?

According to OECD GLP, yes.

❝ We have been asked by the inspector to add the Study Completion Date in the Study Plan.

Again if you stick to the definition of the study completion date, it is just not possible to have it in the study plan. May be you can try and discuss with the inspector ?

❝ We manually fill in the date the Study Director signs the final report, on the Study Plan.

I really don't see the added value of writing anything in the study plan once the study is completed... I'd be interested in hearing the justification the inspector gives, if you get one.

Regards
Ohlbe

Complete thread:

• dates in study plan of bioanalytical study Ken Peh 2013-03-16 13:44 
  • dates in study plan of bioanalytical study Ohlbe 2013-03-17 01:10
    • dates in study plan of bioanalytical study Ken Peh 2013-03-18 17:23
      • dates in study plan of bioanalytical studyOhlbe 2013-03-18 18:35
        • dates in study plan of bioanalytical study Ken Peh 2013-03-20 16:45