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BEAZ ★ India, 2008-07-24 16:05 (6545 d 04:09 ago) Posting: # 2077 Views: 6,764 |
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Dear all, It would be greatly appriciated  if some one clarify the below issues In a intramuscular injection BE study (in case of Susp) what condition should be followed fasting or fed? Is there any recommendation or guidance specifying this? thanks in advance Regards — Alhas |
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ElMaestro ★★★ Denmark, 2008-07-25 11:01 (6544 d 09:13 ago) @ BEAZ Posting: # 2081 Views: 5,851 |
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Hi Alhas, sometimes the intestinal absorption (rate and/or extent) of an oral drug can be affected by food intake / food factors. When comparison between two formulations is done, one should accordingly make sure that the formulations are not too different in terms of the effect of food. When you inject a solution/suspension you bypass gastrointestinal absorption. Therefore, I don't see a need to consider food effects. I am not aware of any parenteral drug product with an SPC in which it is stated that food may affect its pharmacological properties. If one such exists it would be tremendously interesting to hear about it. Darn, now I got really hungry. Best regards EM. |
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BEAZ ★ India, 2008-07-25 14:11 (6544 d 06:03 ago) @ ElMaestro Posting: # 2082 Views: 6,012 |
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Hai Maestro, Thanks. As an IM there is no GI transit or there is no effect of food which may interfere with the PK. But for IM studies all CROs propose a fasting study so just want to know is there any specific recommendation and ethically is it acceptable. Best regards — Alhas |
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H_Rotter ★ Germany, 2008-07-25 14:35 (6544 d 05:39 ago) @ BEAZ Posting: # 2083 Views: 5,782 |
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Dear Alhas! ❝ But for IM studies all CROs propose a fasting study [...] Do you really have access to procedures from all CROs? That's quite a lot! Corporate espionage involved? How much did you pay?  ❝ so just want to know ethically is it acceptable. I would see it the other way 'round. A >14 hours fast (≥10 h pre-dose, 4 h post-dose) for oral administration is ethically only acceptable, because the study's target may not be demonstrated otherwise. If the formulation's absorption simply cannot be influenced by food (see ElMaestro's post), I would consider it unethically not to administer after breakfast. BTW, logistics would be much easier then (it's always nasty to serve breakfast when for some drugs there's frequent sampling due to the expected Tmax). Regards, Hermann |
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ElMaestro ★★★ Denmark, 2008-07-25 14:59 (6544 d 05:15 ago) @ BEAZ Posting: # 2084 Views: 5,735 |
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Hi, you mentioned all CROs propose a fasted study. This is a little odd to me, but perhaps you could comment on the nature or properties of the API so it is easier to understand the context? Or..... this is purely speculation: Do you think the CROs you have been in contact with find it difficult to analyse plasma with a lot of lipid components? After all, the various lipids (phosphatidyl choline and similar ill-behaving nasty molecules) may in some cases have funny effects on chromatolophystic analyses. EM. |
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Ohlbe ★★★ France, 2008-07-25 19:25 (6544 d 00:49 ago) @ ElMaestro Posting: # 2085 Views: 5,565 |
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Dear ElMaestro, ❝ Or..... this is purely speculation: Do you think the CROs you have been in contact with find it difficult to analyse plasma with a lot of lipid components? After all, the various lipids (phosphatidyl choline and similar ill-behaving nasty molecules) may in some cases have funny effects on chromatolophystic analyses. True. But you will have exactly the same problems after lunch and dinner... And you can't keep the subjects fasting for days  Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2008-07-25 19:35 (6544 d 00:39 ago) @ ElMaestro Posting: # 2086 Views: 5,850 |
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— 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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BEAZ ★ India, 2008-07-30 14:52 (6539 d 05:22 ago) @ Helmut Posting: # 2100 Views: 5,668 |
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Dear all, Thanks a lot  Regards — Alhas |
Ing. Helmut Schütz