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suchit_bhavsar ★ India, 2012-03-14 06:13 (4807 d 11:03 ago) Posting: # 8270 Views: 3,694 |
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Hello to all of you We are conducting a bioequivalence study on some xx drug. Our protocol says that some specific laboratory parameter is there to be evoluted in check out of period 1. One subject dropped due to medical ground during this period. Now confusion is there that we have to evalute that laboratory parameter for that subject or not ? With warm regards, Suchit |
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drgunasakaran1 ★★  2012-03-14 11:05 (4807 d 06:10 ago) @ suchit_bhavsar Posting: # 8271 Views: 3,050 |
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Dear Mr.Suchit Bhavsar, I hope that the additional laboratory parameter you planned to evaluate during the check out of Period I is for Safety reasons, then you have to evaluate that laboratory parameter for the dropped out subject too. — 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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Helmut ★★★   Vienna, Austria, 2012-03-14 17:10 (4807 d 00:05 ago) @ suchit_bhavsar Posting: # 8274 Views: 3,039 |
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Dear Suchit! ❝ Our protocol says that some specific laboratory parameter is there to be evoluted in check out of period 1. One subject dropped due to medical ground during this period. Now confusion is there that we have to evalute that laboratory parameter for that subject or not ? Follow the protocol – but: (Almost) all protocols I have seen require drop-outs to perform the full post-study exams. I would suggest to do so even if you required just a part of the assessments after period 1 – especially since the subject dropped out for medical reasons. — 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 |
Ing. Helmut Schütz