Bioequivalence and Bioavailability Forum

Dear Ms.Varsha,

It varies with the different activities captured in the CRF of BE study.

For Eg., Water measurement record, Food preparation and distribution record (in case of Fed study), Pre-dose compliance record, Dosing Record, Vital measurement record need to be checked immediately. Other activities such as custodian form, volunteer movement record etc., need not be checked immediately but in routine practice during the conduction of BE studies, it will be checked on the same day.

No guidelines states that the Principal Invesigator need to be present during the time of dosing. But, most of the sponsors are asking that the dosing should always be done in the presence of Principal Investigator and the same need to be captured in the protocol as well as the dosing record need to be signed by Principal Investigator as Supervising Investigator.

Regards,

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post. [Helmut]