Dear all!!!!!
I have a problem. I have developed a tablet with overage and have bioequivalence done for the same.Now i have to take out the overage in the same formulation and adjust the weight of the tablet with anyother excipient already present in the tablet like lactose or MCC, Do I need to repeat the bioequivalence.Does anybody know anyguideline for avoiding repition of this BE study.

yes, you have to do bioequivallence study again because ICH suggest that if any change in exicipent or its strenth of exicipent of any formulation you have to repeat study. Exicipent may cause toxicity and its assay method may change.