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kasi ☆ 2007-02-07 11:44 (7075 d 13:57 ago) Posting: # 505 Views: 6,821 |
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hi good afternoon i have a small query regarding drug administration actually in BA/BE studies we are conducting fasting and fed studies to know the effect of food on bioavailability. apart from these two some times we are administering the drug with apple sauce (coated particles sprinkled on spoon ful of apple sauce). what is the purpose of this type? is there any regulation for this type of administration? thank you — Regards, Raaz |
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Helmut ★★★   Vienna, Austria, 2007-02-07 13:08 (7075 d 12:33 ago) @ kasi Posting: # 508 Views: 6,036 |
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Dear kasi! ❝ [...] some times we are administering the drug with apple sauce (coated particles sprinkled on spoon ful of apple sauce). what is the purpose of this type? I such a study you may show that the enteric coating is still working (which is not obvious, since different brands of apple sauce come with pHs of 3.5-5.5). This kind of administration may increase compliance in subjects having difficulties swallowing the intact capsule (children, elderly). If BE is demonstrated, you may add it to the SPC of the product. ❝ is there any regulation for this type of administration? Hhm, I don't think so... — 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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hirenpharm ☆ Ahmedabad, 2007-03-01 11:39 (7053 d 14:03 ago) (edited on 2007-03-01 13:19) @ kasi Posting: # 549 Views: 5,463 |
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Dear K, it is generally recommended...in followings In BE study follow the dosage regimen and method of administration which is actually in clinical practice... Administration with apple sauce is generally for anti psychotic or anti epileptic drugs...recently for Valporic acid Sometimes it is to be proved that the particular drug formulation has higher BA in presence of say apple sauce...or more compatibility as compare to water... HM  Edit: Full quote removed. [Helmut] |
Ing. Helmut Schütz