Bioequivalence and Bioavailability Forum

Dear Ohlbe,

Thanks so much for your promptly reply.

Further question, let's say that our calibration curve range is 2-800 ng/mL with LQC at 6 ng/mL, MQC at 400 ng/mL and HQC at 750 ng/mL.

The study drug is BCS class 4 and 50 subjects were enrolled in the study.

We found Cmax of each subjects are quite varied in range from ~150 ng/mL to ~600 ng/mL. One subject has Cmax ~150 ng/mL, Four subjects have Cmax ~250 ng/mL, Around 50% of subjects have Cmax around 300-400 ng/mL and the rest 50% of subjects have Cmax around 400-600 ng/mL. While we found the low Cmax subject when we have already done half of sample analysis.

Do we still need to add addition QC or adjust the curve range? If yes, how can I do it? like where to place the extra QC in the same curve range to comply the Guideline (at least 2 QCs fall within the range of concentration)? or How to narrow the curve range?

Sorry if this might annoy you but I really need the answer to give to our inspector and Regulatory authorities.

Thanks in advance for your kindness help!

Sincerely,

TK

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Edit: Please don’t use line-breaks within sentences in your posts – makes them difficult to follow and forces users to sroll down… [Helmut]