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Back to the forum  2018-07-20 18:54 CEST (UTC+2h)

Regarding US FDA guidelines [Bioanalytics]

posted by sri - 2009-07-09 13:01  - Posting: # 3945
Views: 3,008

Dear all,
Please clarify me the below sentense which is present in 'Guidance for Industry Bioanalytical Method Validation'.

The calibration (standard) curve should cover the expected unknown sample concentration range in addition to a calibrator sample at lower limit of quantification.


Regards,
Sri

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