Abrent Value [Bioanalytics]
Dear Sir,
Kindly advice on below mentioned case:
We have done one study containing parent drug and it's active metabolite. During reveiwing the data, it is observed that abrent concentration observed in metabolite profile however parent drug shows no abrent concetration (parent drug concentration is BLQ up to first three time point whereas in metabolite one abrent concentration observed between two above LLOQ concntration). In this case is it necessary to analyzed metabolite under "Abrent Concntration code"? Kindly advice on that. With regard to this i would like to clear that we have same analytical method with diffrent Calibration Curve range for parent drug and it's metabolite.
Regards,
Auditor
Kindly advice on below mentioned case:
We have done one study containing parent drug and it's active metabolite. During reveiwing the data, it is observed that abrent concentration observed in metabolite profile however parent drug shows no abrent concetration (parent drug concentration is BLQ up to first three time point whereas in metabolite one abrent concentration observed between two above LLOQ concntration). In this case is it necessary to analyzed metabolite under "Abrent Concntration code"? Kindly advice on that. With regard to this i would like to clear that we have same analytical method with diffrent Calibration Curve range for parent drug and it's metabolite.
Regards,
Auditor
Complete thread:
- Abrent Valueauditor 2010-08-30 12:22 [Bioanalytics]
- Abrent? Jaime_R 2010-08-30 13:01
- Abrent Value keshav khude 2010-08-31 07:36
