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RegisterFood effect [Regulatives / Guidelines]
Dear All,
I was reviewing this revised guidance of EU for modified release formulation and i have one problem of understanding in the process mentioned in line 362, 363 and 364 about conduction of food effect study with compare to line 365, 366 & 367.
As per line 362 to 364, Food effect study is only require to conduct if the effect of the same is observed on Immediate formulation. I interpret it as only fasting is enough if the effect of food is absence or only fed is requires to be perform.
But as per the line 365 to 367, fast and fed both are suggested to be performed by default. Is it mean that fast and fed is necessary to perform in all cases however only fed is requires if effect of food is known as per IR formulation.
Please clear me on this to get the correct understanding about when to perform fasting and when to conduct fasting and fed both.
Thank you.
Regards,
Compliance
Edit: Subject line changed and moved to the suitable thread. [Helmut]
I was reviewing this revised guidance of EU for modified release formulation and i have one problem of understanding in the process mentioned in line 362, 363 and 364 about conduction of food effect study with compare to line 365, 366 & 367.
As per line 362 to 364, Food effect study is only require to conduct if the effect of the same is observed on Immediate formulation. I interpret it as only fasting is enough if the effect of food is absence or only fed is requires to be perform.
But as per the line 365 to 367, fast and fed both are suggested to be performed by default. Is it mean that fast and fed is necessary to perform in all cases however only fed is requires if effect of food is known as per IR formulation.
Please clear me on this to get the correct understanding about when to perform fasting and when to conduct fasting and fed both.
Thank you.
Regards,
Compliance
Edit: Subject line changed and moved to the suitable thread. [Helmut]
Complete thread:
- Draft EMA MR formulations GL published! Ohlbe 2013-03-15 12:10 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Housekeeping suggestions Helmut 2013-03-15 13:28
- Scaling for pAUCs Helmut 2013-03-15 14:19
- Draft EMA MR formulations GL published! ioanam 2013-03-30 17:54
- Topicals → 1995 NfG Helmut 2013-03-30 22:51
- Topicals, generic ElMaestro 2013-03-31 19:26
- Topicals, generic ioanam 2013-04-01 07:51
- Topicals, generic The Outlaw Torn 2013-04-01 08:03
- Topicals, generic ioanam 2013-04-01 07:51
- Clarity on waiving multiple dose study Tina 2013-05-15 14:19
- Hey, it is just a draft! Helmut 2013-05-17 18:49
- Critical review of García-Arieta et al. (2012) Helmut 2013-06-29 19:44
- Hey, it is just a draft! Helmut 2013-05-17 18:49
- SD vs. MD, partial AUCs Helmut 2013-06-21 19:24
- SD vs. MD, partial AUCs Shuanghe 2013-06-25 17:22
- SD vs. MD, partial AUCs Helmut 2013-06-25 19:15
- SD vs. MD, partial AUCs Shuanghe 2013-06-27 11:07
- pAUCs, alternative metrics, alcohol Helmut 2013-06-27 14:38
- SD vs. MD, partial AUCs Shuanghe 2013-06-27 11:07
- SD vs. MD, partial AUCs Helmut 2013-06-25 19:15
- SD vs. MD, partial AUCs Shuanghe 2013-06-25 17:22
- tmax (DR & multiphasic) Helmut 2013-06-22 01:15
- Presentations of the EUFEPS meeting Helmut 2013-07-15 15:50
- ⧫ Deadline approaching ⧫ Helmut 2013-08-16 16:41
- Download comment form Helmut 2013-08-26 11:28
- Food effectCompliance 2013-08-26 12:04
- Food effect Dr_Dan 2013-08-26 16:48
- Variability (MR vs. IR) Helmut 2013-09-12 15:23
Ing. Helmut Schütz