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suchit_bhavsar ★ India, 2011-03-04 12:31 (5587 d 03:23 ago) Posting: # 6703 Views: 6,270 |
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If in safety evaluation any laboratory parameter will be out of range then we will file AE for that correct. Now my question is it will be consider as a post study period 2 AE or after completion of AE study ? and what we will write in study medication ? Period 2 treatment or both the test and reference ? |
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Helmut ★★★   Vienna, Austria, 2011-03-04 17:51 (5586 d 22:03 ago) @ suchit_bhavsar Posting: # 6704 Views: 5,162 |
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Dear Suchit, again: Please follow the Forum's Policy in the future - you have been notified numerous times. Is it really that complicated to say “hello”‽ ❝ If in safety evaluation any laboratory parameter will be out of range then we will file AE for that correct. Yes. ❝ Now my question is it will be consider as a post study period 2 AE or after completion of AE study ? I don’t know your SOPs. Most people would consider them as post study - but this is nitpicking, of course. I came only once across a case where lab evaluations (besides screening) were performed at hospitalizations and after both periods… ❝ and what we will write in study medication ? Period 2 treatment or both the test and reference ? Any cross-over study should be designed in such a way that no residual effects of period 1 are substantial in period 2 (= no carry-over). Following this rationale you should code the AE to the treatment of period 2, IMHO. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2011-03-04 18:10 (5586 d 21:44 ago) @ Helmut Posting: # 6705 Views: 5,131 |
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Hi HS, ❝ Any cross-over study should be designed in such a way that no residual effects of period 1 are substantial in period 2 (= no carry-over). Following this rationale you should code the AE to the treatment of period 2, IMHO. Wow, I never gave that a thought. If an AE occurs after period 1 at any time during the washout period, then the AE is a period 1 AE. My intuition (we both know it's frequently malfunctioning as my cerebral capacity is dictated by a spongy structure approximately the size of a walnut) suggests me that one can assign the AE to period 2 if it occurs within the same washout time after dosing in that period. Or whut? — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2011-03-04 19:20 (5586 d 20:33 ago) @ ElMaestro Posting: # 6707 Views: 5,196 |
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My Capt'n! ❝ If an AE occurs after period 1 at any time during the washout period, then the AE is a period 1 AE. My intuition (we both know it's frequently malfunctioning as my cerebral capacity is dictated by a spongy structure approximately the size of a walnut)… Welcome to the club! ❝ … suggests me that one can assign the AE to period 2 if it occurs within the same washout time after dosing in that period. Yessir! You are only mixing two things up: that’s Reasoning - not Intuition.  ❝ Or whut? No idea. Nobody (?) follow this concept anyhow and tries to get the post-study evaluations as soon as possible. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz