Bioequivalence and Bioavailability Forum

Dear Member

We are at the edge of start one of the injection study where we have to give six injections to subject in each period to achieve steady state. now each injection will be administer with the gap of 1 month. total duration of single period is around six month and same for the period II.

Now the actual challenge is, dosing date of each subject is different based on their availability and willingness to participate in the study. due to this reason, we are going to use two different lot of RLD in same study due to having very short self-life of RLD product.

My question is, how FDA will take this usage of 02 different lot of RLD in single study? do we need to normalize the data of all the subjects based on the differences of the RLD lot? does the usage of two different lot will be taken as treatment effect and will it be justified?

Regards,

Mithu

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Edit: Category changed; see also this post #1. [Mittyri]