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RegisterIt's breakfast time [Design Issues]
Hello Andrew!
Happy Ireland
. In Kiel, where I'm going today it is ever raining.
See the new EMA guidance, 4.1.4 Study conduct, page 8:
"In case the study is to be performed during fed conditions, the timing of administration of the drug product in relation to food intake is recommended to be according to the SmPC of the originator product. If no specific recommendation is given in the originator SmPC, it is recommended that subjects should start the meal 30 minutes prior to administration of the drug product and eat this meal within 30 minutes."
Seems this is not restricted to only high fat.
See further FDA Guidance "Food-Effect Bioavailability and Fed Bioequivalence Studies", page 6:
"Fed Treatments: Following an overnight fast of at least 10 hours, subjects should start the recommended meal 30 minutes prior to administration of the drug product. Study subjects should eat this meal in 30 minutes or less; however, the drug product should be administered 30 minutes after start of the meal. The drug product should be administered with 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose."
May be other guidances have also some timing suggestions. Too lazy to read it for you
.
Don't know.
❝ The sun is shining here in Ireland! 
Happy Ireland
. In Kiel, where I'm going today it is ever raining.❝ Does anyone have a view on the timing of the high fat breakfast? ...
❝ Is there any evidence (or guidance) to support one approach over another?
See the new EMA guidance, 4.1.4 Study conduct, page 8:
"In case the study is to be performed during fed conditions, the timing of administration of the drug product in relation to food intake is recommended to be according to the SmPC of the originator product. If no specific recommendation is given in the originator SmPC, it is recommended that subjects should start the meal 30 minutes prior to administration of the drug product and eat this meal within 30 minutes."
Seems this is not restricted to only high fat.
See further FDA Guidance "Food-Effect Bioavailability and Fed Bioequivalence Studies", page 6:
"Fed Treatments: Following an overnight fast of at least 10 hours, subjects should start the recommended meal 30 minutes prior to administration of the drug product. Study subjects should eat this meal in 30 minutes or less; however, the drug product should be administered 30 minutes after start of the meal. The drug product should be administered with 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose."
May be other guidances have also some timing suggestions. Too lazy to read it for you
.❝ ... Is one approach likely to increase variability compared to another?
Don't know.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Timing of high-fat breakfast Dr Andrew Leary 2010-08-24 12:13 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- It's breakfast timed_labes 2010-08-24 13:00
- Yummz ElMaestro 2010-08-24 15:09
- Yummz Dr Andrew Leary 2010-08-24 16:22
- Reading matters Helmut 2010-08-24 16:34
- It's breakfast time Dr Andrew Leary 2010-08-24 16:20
- It's breakfast time Pavidus 2010-08-25 14:11
- It's breakfast time Dr Andrew Leary 2010-08-25 14:52
- It's breakfast time ElMaestro 2010-08-25 15:14
- It's breakfast time Ohlbe 2010-08-25 16:07
- It's breakfast time Dr Andrew Leary 2010-08-25 16:15
- It's breakfast time Dr_Dan 2010-08-25 15:33
- It's breakfast time Dr_Dan 2010-08-25 15:49
- It's breakfast time Helmut 2010-08-25 16:22
- It's breakfast time Pavidus 2010-08-26 10:02
- It's breakfast time Helmut 2010-08-25 16:22
- It's breakfast time Dr_Dan 2010-08-25 15:49
- It's breakfast time Dr Andrew Leary 2010-08-25 14:52
- It's breakfast time Pavidus 2010-08-25 14:11
- Yummz ElMaestro 2010-08-24 15:09
- It's breakfast timed_labes 2010-08-24 13:00
Ing. Helmut Schütz