Adverse event [GxP / QC / QA]
hi ,
I required some clarification (BA-BE studies)
In two Period study with ambulatory collection , I had performed lab investigation in check in and at check out of P-II. Also I have critera in protocol for lab investigation at last ambulatory.
I didn't get any value of lab paramenter that is significant at the time of check out lab investigation of P-II but got value significant at ambulatory lab investigation. In this case I consider it its due to drug administered. I confused bcoz it is not obtained at check out lab investigation and at that time drug concentration in body is higher than at time of ambulatory.
I required some clarification (BA-BE studies)
In two Period study with ambulatory collection , I had performed lab investigation in check in and at check out of P-II. Also I have critera in protocol for lab investigation at last ambulatory.
I didn't get any value of lab paramenter that is significant at the time of check out lab investigation of P-II but got value significant at ambulatory lab investigation. In this case I consider it its due to drug administered. I confused bcoz it is not obtained at check out lab investigation and at that time drug concentration in body is higher than at time of ambulatory.
Complete thread:
- Adverse eventBhavesh 2009-08-14 05:04
- Adverse event kiranActimus 2009-08-14 10:14
- Adverse event Bhavesh 2009-08-17 07:41
- Adverse event kiranActimus 2009-08-17 09:02
- Adverse event taresh41 2009-08-17 13:13
- Adverse event Bhavesh 2009-08-17 07:41
- Adverse event kiranActimus 2009-08-14 10:14