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RegisterFood effect [Regulatives / Guidelines]
Dear Compliance
This was a topic at the EUFEPS meeting in Bonn followed by an intensive discussion. Andrzej Dzierbicki from Polpharma pointed out that a food effect study of the new MR formulation should be considered sufficient as food effect related to drug substance/IR formulation is known. Such food effect study results of the new MR formulation can be compared with historical/published data of food effect of an IR formulation irrespective of whether clinically significant food effect was observed for the IR formulation or not. Studies are sufficiently standardized to allow for rough estimation of effect size. However, it is not clear how the PK working group will react on this objection. We need to see the final version of the guideline.
Kind regards
Dan
This was a topic at the EUFEPS meeting in Bonn followed by an intensive discussion. Andrzej Dzierbicki from Polpharma pointed out that a food effect study of the new MR formulation should be considered sufficient as food effect related to drug substance/IR formulation is known. Such food effect study results of the new MR formulation can be compared with historical/published data of food effect of an IR formulation irrespective of whether clinically significant food effect was observed for the IR formulation or not. Studies are sufficiently standardized to allow for rough estimation of effect size. However, it is not clear how the PK working group will react on this objection. We need to see the final version of the guideline.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
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 effect Compliance 2013-08-26 12:04
- Food effectDr_Dan 2013-08-26 16:48
- Variability (MR vs. IR) Helmut 2013-09-12 15:23
Ing. Helmut Schütz