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jag009 ★★★ NJ, 2012-07-10 19:15 (5097 d 12:59 ago) Posting: # 8918 Views: 8,090 |
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Hi, Is it possible to fail a BE study on applesauce give that the fasting BE (non-applesauce) study is perfectly bioequivalent. The drug has intrasubject CV in the 15-20% range, not HVD. The 90% CI has a upper limit of 120% (still less than 125). Fed study is BE was well. I mean if everything goes well, no dropping of capsule content, subject swallowed all the apple sauce + drug content. Just curious if the capsule shell itself would have an effect. Thanks John |
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Helmut ★★★   Vienna, Austria, 2012-07-10 20:07 (5097 d 12:08 ago) @ jag009 Posting: # 8919 Views: 6,834 |
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Hi John! ❝ Is it possible to fail a BE study on applesauce give that the fasting BE (non-applesauce) study is perfectly bioequivalent. […] Fed study is BE was well. Would be a surprise. pH of apple sauce is ~3.2–3.5; acidic but well above gastric conditions. Can’t imagine that the coating would be affected in the short time the pellets are sprinkled.  ❝ Just curious if the capsule shell itself would have an effect. Very (very) unlikely, 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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jag009 ★★★ NJ, 2012-07-10 22:15 (5097 d 09:59 ago) @ Helmut Posting: # 8920 Views: 6,723 |
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Thanks Helmut. I ran opened vs non-opened capsule reference only study before but never sprinkled vs sprinkled. John |
Ing. Helmut Schütz