Bioequivalence and Bioavailability Forum

Dear drgopal,

❝ Can we have a separate acceptable range on our own (+/- 10-15% of the range) as our company's range beside the reference range?

In addition to Helmut's response: if you were to adopt such a system you would need to discuss the extended range on a parameter-by parameter basis, not just extend everything by 10 %. This would be OK for e.g. SGOT - 44 IU/l instead of 40 is no big deal, if the elevation is isolated. But take sodium, with normal ranges of 135-145 mmol/l. Extending the range to 122-159 would definitively not be acceptable ! And once again you can't interpret each parameter separately, you also have to look at the complete picture. And this is the investigator's job, not an SOP's.

Regards
Ohlbe