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ISR sample selection [Bioanalytics]

posted by Smitha - India, 2018-11-29 11:09  - Posting: # 19656
Views: 547

Hello,

For BE studies, some of the CRO Bioanalytical Labs select the Cmax time point as the sample for ISR analysis (is also defined in their SOP). The guidelines talk about selection of samples 'around the Cmax'.

How appropriate is it to generate another set of data for a critical PK parameter as Cmax? (even if the guidelines indicate that these values should not be used for study conclusion).

Would appreciate the members thoughts on this.

Thank you.

Regards,
Smitha

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