Bioequivalence and Bioavailability Forum

Dear Mr Santhosh,

❝ is it right decision to acknowledge in Note to file or we need to versionize the protocol notify to DCG(I).

No. You cannot capture the change in BMI and addition of some pathological tests as 'Note to File'. You need to raise either Protocol amendment or Change of version of protocol since you are planning to change the inclusion criteria such as BMI and some pathological tests.

❝ Meanwhile please suggest BMI criteria for ANVISA submission.

As per ANVISA's Resolution - RE nº 1170 of 19 May 2006, the weight of the subjects shall be within a limit of +/- 15% of the weight considered normal for men and women, taking into account height and physical structure In case of contraceptives, one recommends that the limit of weight is ± 10 %;