Bioequivalence and Bioavailability Forum

❝ In a BA/BE study a protocol designed with two way crossover where the reference product name mentioned as XXXXX manufactured by XYZ. In general IPs need to be received to CRO as per the details of protocol along with the regulatory approval (T-License) for the study (if applicable). If Reference IPs received are not matching with details mentioned in protocol and regulatory approval 'like Name and manufactured by' can we conduct the study by generating an amendment to the protocol.

I my experience, reference product details is a part of study design. If any study design is changed inculding reference product details (not matching with protocol), you need to take approval for the change (version number of the protocol will be changed and submitted to DCGI for approval with ethics committee approval letter).

Present scenario of DCGI is not known, so i am in doubt that DCGI will agree with only amendment made. Thanks.

Regards; RCG