Bioequivalence and Bioavailability Forum

Dear Mr Balavivekanand,

If there is change only in the Trade Name of the Reference product and manufacturer details, you can raise protocol amendment for the same. You need to get Ethics committee approval for your amendments and send an Intimation letter to the Regulatory body along with your Ethics Committee approved protocol amendment before initiating the study.

Kindly be informed that if there is a change in the dosage form, strength of the reference product, frequency of administration etc., we need to get approval from both the Ethics Committee and Regulatory body before conducting the study.