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Louise ☆ New Zealand, 2013-05-24 05:33 (4371 d 07:02 ago) Posting: # 10637 Views: 4,991 |
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It's recommended that some drugs (anti-diabetic in particular) are dosed with a 20% glucose solution rather than with water to reduce potential AEs in healthy volunteers. Does this have any effect on absorption of the drug? Edit: Category changed. Please see the Forum’s Policy (aka “Good morning!”). [Helmut] |
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Dr_Dan ★★ Germany, 2013-05-24 12:06 (4371 d 00:29 ago) @ Louise Posting: # 10640 Views: 4,063 |
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Dear Luise If co-administration of 20% glucose solution in order to reduce potential AEs in healthy volunteers has an effect on absorption of the drug, does this matter? If you are interested just in bioavailability this might be a question but if you refer to bioequivalence you should keep in mind that th co-administration would only affect the solubilized drug, the comparison of test and reference formulation would not be affected. The purpose of bioequivalence studies is to detect possible impact of different formulations on the pharmacokinetics of the investigated drug and if both formulations are administered the same way everything is fine since absorption is a characteristic of the drug substance itself and is unaffected by formulation. I hope this helps Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★   Vienna, Austria, 2013-05-24 18:22 (4370 d 18:12 ago) @ Dr_Dan Posting: # 10644 Views: 4,063 |
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Dear Dan! ❝ […] absorption is a characteristic of the drug substance itself and is unaffected by formulation. <nitpicking> Disagree. — 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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Louise ☆ New Zealand, 2013-05-27 03:16 (4368 d 09:18 ago) @ Dr_Dan Posting: # 10660 Views: 4,049 |
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Thanks Dr Dan. As the test and reference products are administered under the same conditions I wouldn't have thought this would be an issue. I hadn't seen this question from regulatory authorities before and haven't been able to locate any studies on glucose administration and drug absorption. |
Ing. Helmut Schütz