Dear Madam/Sir,
In case BE Studies are found in agreement with those of Reference Product ( RLD ),is it necessary to carry out IVD profile in min.3 Media,and to show that F1,F2 similarity factors are as per the requirement? In our opinion , there is no need to carry out IVD Profile if BE Studies are found satisfactory.Please let us have your views on the same.
Regards,
Dr.Barve