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Drug concentration <LLQ [Bioanalytics]

posted by GM - India, 2018-06-29 05:47  - Posting: # 18992
Views: 805

Hello All,

Hope all are doing well.

As per the Bioanalytical guidance of FDA, all values <LLQ should be declared as zero.

But my doubt is, is there any possibility to use the actual values measured for calculating key parameters?

If yes, how this can be justify?

B’coz, we are not getting best fit (Rsq<0.8) when considering zero instead of actual values.

Thankyou in advance.

GM.

Best Regards,
GM

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