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patilatu ☆ 2010-12-30 08:20 (5659 d 18:22 ago) Posting: # 6355 Views: 6,465 |
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Dear All, I hope, you must have had a wonderful Christmas!!! Merry Christmas to you all and happy new year 2011. An example test meal would be: two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk. Substitutions in this test meal (e.g., beef instead of bacon) can be made as long as the meal provides a similar amount of calories from protein, carbohydrate, and fat and has comparable meal volume, density, and viscosity. In general, completely vegetarian meals are not recommended. I have a small query regarding these two highlighted points in the above mentione para from Draft guidance on Amantadine HCL, recommended Nov 2010. In the countries like India, where eating beef and bacon may not be prefered by all the volunteer population, do we have any other recommended substitute diet like chicken or cheese having equal quantity of calories from carbs, fats and proteins. Can we substitute cheese with beefs and bacons and keeping egg in the menu as complete vegeterian diet is not recommended. Thanks in advance. |
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Phaneendra.K ☆ 2010-12-31 15:43 (5658 d 10:59 ago) @ patilatu Posting: # 6363 Views: 5,565 |
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Dear Patilatu, This is being done by many CROs. Instead of beef and bacon fried Chicken, Omellete, french fries (with butter) are included in the meal menu as high fat high calorie breakfast. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] — Thanks and Regards, PK |
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Helmut ★★★   Vienna, Austria, 2010-12-31 17:30 (5658 d 09:12 ago) @ patilatu Posting: # 6372 Views: 5,652 |
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Dear Patilatu! ❝ An example test meal would be: two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk. Substitutions in this test meal (e.g., beef instead of bacon) can be made as long as the meal provides a similar amount of calories from protein, carbohydrate, and fat and has comparable meal volume, density, and viscosity. In general, completely vegetarian meals are not recommended. Quoting from FDA's GL on Amantadine HCl (11/2010). ❝ In the countries like India, where eating beef and bacon may not be prefered by all the volunteer population, do we have any other recommended substitute diet like chicken or cheese having equal quantity of calories from carbs, fats and proteins. Can we substitute cheese with beefs and bacons and keeping egg in the menu as complete vegeterian diet is not recommended. OK, India’s GL states: Studies in the fed state require the consumption of a high-fat breakfast before dosing. Such a breakfast must be designed to provide 950 to 1000 KCals. At least 50% of these calories must come from fat, 15 to 20% from proteins and the rest from carbohydrates. The vast ethnic and cultural variations of the Indian subcontinent preclude the recommendation of any single standard high fat breakfast. Protocol should specify the suitable and appropriate diet. I would not bother too much about a substitution (although I'm wondering for many years what FDA means by “viscosity” – of solids?!)… A much more important point is the acceptability of foreign data. Gastric motility in vegetarians is significantly reduced.* Vegetarians should be excluded per protocol. What about states like Gujarat, where >95% of the population are vegetarians? It’s a bad idea to come up with a substitute which will be acceptable for volunteers – if they are vegetarians in real life and change their habits during the study driven by the remuneration.
— 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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achintparikh ☆ India, 2011-02-17 12:04 (5610 d 14:38 ago) @ patilatu Posting: # 6642 Views: 5,385 |
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❝ This is with regard to high fat high calorie breakfast given to healthy volunteers participating in BA/BE study of antihyperlipidemic drugs. Generally, hyperlipidemic patients are on controlled diet with low fat and calorie. so, to resemble the physiology of gastrointestianl tract, the meal i.e. pre dose breakfast should be given which having normal fat and calorie content. The pre dose breakfast will definately affect the gi physiology and kinetic of the formulation. So, considering this fact, the normal pre dose breakfast should be given in food effect study of antihyperlipidemic drug e.g. Atorvastatin. Kindly comment |
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Dr_Dan ★★ Germany, 2011-02-17 13:10 (5610 d 13:32 ago) @ achintparikh Posting: # 6643 Views: 5,302 |
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Dear achintparikh I do not understand your concern. In general BE is required to be studied in healthy volunteers and not in patients. The objective of a bioequivalence study is not the investigation of the pharmacokinetics of the drug entities itself in specific populations (patients), but the comparison of the pharmacokinetic profiles of galenic preparations. In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations. This holds also true for antihyperlipidemic drug like atorvastatin. If you want to study the BA in patients you do not have to stick to the bioequivalence guideline, right? Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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achintparikh ☆ India, 2011-02-18 09:55 (5609 d 16:47 ago) @ Dr_Dan Posting: # 6647 Views: 5,152 |
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As far as possible, the condition should be matched with real scenario. And i think, this is possible for BE study of Atorvastatin like drug |
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Dr_Dan ★★ Germany, 2011-02-18 12:57 (5609 d 13:45 ago) @ achintparikh Posting: # 6649 Views: 5,168 |
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❝ As far as possible, the condition should be matched with real scenario. And i think, this is possible for BE study of Atorvastatin like drug Sorry, but this is nonsense. A BE study is an in-vivo quality investigation and must not reflect clinical use. — Kind regards and have a nice day Dr_Dan |
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kishorpatil ☆ 2011-02-18 11:40 (5609 d 15:02 ago) @ patilatu Posting: # 6648 Views: 5,230 |
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Dear Patilatu, As per Mr.Phaneendra script, he was told correctly as Instead of beef and bacon fried Chicken, Omellete, french fries (with butter) are included in the meal menu as high fat high calorie breakfast but the contents of the composition and calories should be equivalent to regulatory submission otherwise they will not accept your data. I hope this will help to you Regards Kishor patil Edit: Full quote removed, like in all your previous responses. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2011-02-18 16:15 (5609 d 10:27 ago) @ kishorpatil Posting: # 6650 Views: 5,194 |
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Dear Kishor, you managed it already last December to become the first forum member ever (!) to be blocked from editing. The team of moderators is fed up with editing all your posts. This is the final warning. The next time you reply to a post including the entire original post (aka TOFU) you will be blocked indefinitely without further notice.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz