Smitha
☆    

India,
2018-11-29 11:09

Posting: # 19656
Views: 1,031
 

 ISR sample selection [Bioanalytics]

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
Kintan Patel
☆    

India,
2018-11-29 11:26

@ Smitha
Posting: # 19658
Views: 950
 

 ISR sample selection

Dear Madam,

I do agree with you that it is not appropriate to generate another set of data by selecting ISR sample as Cmax Sample.It is advisable to select ISR sample near to Cmax value not exactly Cmax Value.If your Cmax Value is not within the ISR acceptance or deviating more than 30 % and if it is impacting your study results then it will be very difficult to justify.


Thank You.
Kintan
Ohlbe
★★★

France,
2018-11-29 17:50

@ Smitha
Posting: # 19661
Views: 926
 

 ISR sample selection

Dear Smitha,

» 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).

I don't see a real problem here: as you say, the guidelines clearly indicate that the ISR value should not be used for the PK/stats.

Actually, it sort of helps to avoid some other issues. If you write in your SOP that you will systematically repeat the Cmax sample, there will be no discussion regarding how you selected the samples to be re-analysed and possible bias in sample selection.

Regards
Ohlbe
jag009
★★★

NJ,
2018-11-29 18:00

@ Ohlbe
Posting: # 19662
Views: 924
 

 ISR sample selection

» I don't see a real problem here: as you say, the guidelines clearly indicate that the ISR value should not be used for the PK/stats.

I agree with Ohlbe as well

John
Smitha
☆    

India,
2018-11-30 06:45

@ jag009
Posting: # 19664
Views: 878
 

 ISR sample selection

Thank you Kintan, Ohlbe and Jag
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