SAP? [Study As­sess­ment]

posted by Shatha – 2022-08-27 13:55 (597 d 00:32 ago) – Posting: # 23239
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Hi Helmut:

❝ before I will go into the details: What does your protocol say?


My protocol requests to use actual sampling times for analysis and lists Ctau and AUCtau as primary PK parameters.
The following are mentioned as possible reasons for exclusion:
*Data from subjects with missing concentration values (missed blood draws, lost samples, samples unable to be quantified, etc.) may be used if some of the PK parameters can be estimated using the remaining data points. Otherwise, data from these subjects will be excluded from the final analysis.
*Subjects, whose bio-analysis data do not provide a complete PK profile, should be excluded from bio-assessment.

No further related information is covered in the protocol and there is no separate SAP.

Thanks

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