Adverse event [GxP / QC / QA]

posted by Bhavesh – India, 2009-08-14 07:04 (6161 d 04:34 ago) – Posting: # 4045
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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.

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