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devender_naik ☆ Hyderabad, 2006-04-27 12:12 (7342 d 22:37 ago) Posting: # 89 Views: 12,493 |
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Dear all, Can any one, tell me why a period of about 21 days/ 28 days is considered for lab parameters (CBP, CUE... etc) as the valid period from the day of screening to participation in the study. Is there any specific reason for it? (As per FDA). |
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Helmut ★★★   Vienna, Austria, 2006-04-27 13:59 (7342 d 20:50 ago) @ devender_naik Posting: # 92 Views: 9,351 |
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❝ Can any one, tell me why a period of about 21 days/ 28 days is considered for lab parameters (CBP, CUE... etc) as the valid period from the day of screening to participation in the study. Is there any specific reason for it? (As per FDA). Hello Devender! Although I have no knowledge about a specific guideline published by the FDA, IMHO I would suggest two weeks as the maximum interval – some sponsors even insist in screening one day (!) before administration… — 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