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Varsha ★ 2012-06-16 10:38 (5113 d 19:57 ago) Posting: # 8749 Views: 6,147 |
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Dear All, For a BA BE study if protocol does not specify any prior or concomitant medication what shall be captured in the integrated study report in the sec. 9.4.7? Secondly, if a subject is having AE in period 02 check-in and was medicated and withdrawn from the study. Does the medication should be considered as Concomitant medication? Thanks and regards, Borsha |
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drgunasakaran1 ★★  2012-06-16 11:02 (5113 d 19:33 ago) @ Varsha Posting: # 8751 Views: 4,754 |
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Dear Mr Borsha, ❝ For a BA BE study if protocol does not specify any prior or concomitant medication what shall be captured in the integrated study report in the sec. 9.4.7? You need to capture the concomitant medication details used during the study for the management of adverse events (if any). You need to discuss about the possible durg-drug interactions of those concomitant medications used, in the section 9.4.7 of Clinical study report. ❝ Secondly, if a subject is having AE in period 02 check-in and was medicated and withdrawn from the study. Does the medication should be considered as Concomitant medication? Yes. It will be considered as Concomitant medication. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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Varsha ★ 2012-06-16 14:22 (5113 d 16:13 ago) @ drgunasakaran1 Posting: # 8752 Views: 4,667 |
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