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Registerregarding elevation of lab parameters [GxP / QC / QA]
Dear all,
We have conducted one BA BE study where at the time of screening, the volunteers were having normal ESR values but the post study safety reports after the drug administration reveals increase clinically significant ESR values and were considered as adverse event for nearly 18 subjects out of 48 subjects. The physician has documented the AE as not related to the drug as there is not linerature evidence for the same.
My concern is, is the documentation correct? What may be the reason for increase of ESR values for all these subjects.
Regards,
Varsha
We have conducted one BA BE study where at the time of screening, the volunteers were having normal ESR values but the post study safety reports after the drug administration reveals increase clinically significant ESR values and were considered as adverse event for nearly 18 subjects out of 48 subjects. The physician has documented the AE as not related to the drug as there is not linerature evidence for the same.
My concern is, is the documentation correct? What may be the reason for increase of ESR values for all these subjects.
Regards,
Varsha
Complete thread:
- regarding elevation of lab parametersVarsha 2014-09-01 14:36
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- regarding elevation of lab parameters ElMaestro 2014-09-01 16:59
- regarding elevation of lab parameters Varsha 2014-09-02 06:47
- regarding elevation of lab parameters ElMaestro 2014-09-02 07:40
- regarding elevation of lab parameters Varsha 2014-09-02 06:47
- regarding elevation of lab parameters ElMaestro 2014-09-01 16:59
Ing. Helmut Schütz