Predose study samples [Bioanalytics]
Hai reddy,
There is no acceptance criteria for predose samples.
But predose sample also considered as blank matrix. So we have criteria for interference in blank matrix (selectivity) mentioned in FDA guidelines. So same will be applicable for predose sample also. However you should follow as per your predefined inhouse SOPs.
with regards,
Rambabu.S
Edit: Full quote removed. Please see this post! [Helmut]
There is no acceptance criteria for predose samples.
But predose sample also considered as blank matrix. So we have criteria for interference in blank matrix (selectivity) mentioned in FDA guidelines. So same will be applicable for predose sample also. However you should follow as per your predefined inhouse SOPs.
with regards,
Rambabu.S
Edit: Full quote removed. Please see this post! [Helmut]
Complete thread:
- Predose study samples Reddy 2009-01-16 18:03
- Predose study samples babun14 2009-02-04 06:01
- Predose study samples moblak 2009-02-16 14:58
- Predose study samplesbabu 2009-02-04 13:57
- Predose study samples Reddy 2009-02-08 11:47
- Predose study samples babun14 2009-02-04 06:01
