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Pandu ★ India, 2012-08-22 16:18 (5059 d 18:18 ago) Posting: # 9091 Views: 2,938 |
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Hello, We are developing suspension formulation and its half-life is 60hrs. USFDA OGD says that two-way crossover study. Can we truncate upto 72hrs for these studies? Is this approved by USFDA? Pls provide inputs. |
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Helmut ★★★   Vienna, Austria, 2012-08-22 17:13 (5059 d 17:23 ago) @ Pandu Posting: # 9093 Views: 2,364 |
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Hi Pandu! ❝ We are developing suspension formulation and its half-life is 60hrs. Are you talking about an oral suspension? ❝ USFDA OGD says that two-way crossover study. Are you referring to a product-specific guidance? ❝ Can we truncate upto 72hrs for these studies? Is this approved by USFDA? Basically yes – provided conditions in the ![[image]](img/uploaded/IAsmall.png) FDA’s guidance are applicable. For details see also this thread.— 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