Bioequivalence and Bioavailability Forum

Dear All,

This is with respect to the above mentioned subject, as reference ranges are slightly changed from lab to lab, because of different methods, reagents used and standards used. Also labs change their reference ranges from time to time.

My query is do we really need to mention the lab normal ranges in the protocol or only name of the tests are sufficient? As earlier we used to mention only name of the tests but during one of the regulatory inspection it was suggested to mention reference ranges in the protocol. Now we have mentioned two different lab facilities in the protocol, and both have slightly different normal ranges for some parameters due to which it becomes difficult which reference ranges to be mentioned in the protocol? Because of which there may be chances that one of the subject's value for one of the parameter is absolutely with normal range as per one lab and for other subject the same value may have to be considered as clinically not significant as analysed at other facility which may confuse when reported in the final report?

Your views in this regards will be highly appreciated.

Regards,

Ratnakar

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Edit: Category changed. [Helmut]