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Mahesh ☆ India, 2014-09-25 11:10 (4290 d 02:49 ago) Posting: # 13578 Views: 4,900 |
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Hi, If the product's BE guideline is not available in such cases can we design the protocol based on general guideline on BA/BE? Still do we need to make control correspondence with USFDA with BE study design and get approval before to proceed BE study? — Mahesh N. Padamwar (Ph.D.) |
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ElMaestro ★★★ Denmark, 2014-09-25 11:57 (4290 d 02:02 ago) @ Mahesh Posting: # 13580 Views: 3,898 |
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Hello Mahesh, ❝ If the product's BE guideline is not available in such cases can we design the protocol based on general guideline on BA/BE? If there is no product-specific recommendation (that's what you mean isn't it?) then you should rely on the general BE guideline but of course it is a good idea to apply a minimum amount of independent thinking; is the product plain and simple or are you dealing with a nightmare like an inhalation product etc? ❝ Still do we need to make control correspondence with USFDA with BE study design and get approval before to proceed BE study? No, controlled correspondence with FDA is a general option and not a requirement unless otherwise explicitly required by the FDA. — Pass or fail! ElMaestro |
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Helmut ★★★   Vienna, Austria, 2014-09-25 15:19 (4289 d 22:40 ago) @ ElMaestro Posting: # 13584 Views: 3,870 |
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Hi ElMaestro, ❝ No, controlled correspondence with FDA is a general option and not a requirement unless otherwise explicitly required by the FDA. Well, if one wants to proceed with a “creative” design – deviating a lot from the ones suggested in general guidance(s) – CC is not a bad idea (see this post). Would be too bad if you submit the study and the FDA refuses to review it “You should have asked us before!”… — 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