Bioequivalence and Bioavailability Forum

Dear All,

After bioanalytical method development and method validation, we will proceed to prepare study plan. According to OECD GLP principles, study plan must have the four dates as below:-

1. Proposed Starting Date:
   
2. Proposed Completion Date:
   
3. Study Initiation Date:
   
4. Study Completion Date:

We can provide the proposed starting date and proposed completion date. However, we can only provide the study initiation date when we actually start the assay and provide the study completion date when we complete the work.

My question is can we write on the existing study plan the date of study initiation date and study completion date ? Or we have to prepare a new page of study plan with all the four dates and attach with the existing study plan ?

What is the right way to do it ? Please advise. Thank you.

Regards,
Ken