Bioequivalence and Bioavailability Forum • dates in study plan of bioanalytical study

dates in study plan of bioanalytical study [Bioanalytics]

posted by Ohlbe – France, 2013-03-17 02:10 (4846 d 13:30 ago) – Posting: # 10209
Views: 5,733

Dear Ken,

❝ According to OECD GLP principles, study plan must have the four dates as below:.

❝ I. Proposed Starting Date:

❝ II. Proposed Completion Date:

❝ III. Study Initiation Date:

❝ IV. Study Completion Date:

OK for (I) and (II) (OECD GLP, section II, § 8.2.3.b: The proposed experimental starting and completion dates).

According to OECD GLP section I, § 2.3.11, Study initiation date means the date the Study Director signs the study plan. So the study director will automatically write (III) when he signs the study plan. No problem.

But where did you see (IV) required in the study plan ? According to OECD GLP section I, § 2.3.12, Study completion date means the date the Study Director signs the final report. How could it be planned in advance in the study plan ?

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

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