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Registercapecitabine ≠ NTID; reference-scaling [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2015-07-08 16:59 (3545 d 23:08 ago) – Posting: # 15052
Views: 15,919
Hi Mittyri,
and
As drug variability has not been reviewed, this guidance is not applicable to highly variables drugs.
Maybe in the meantime they reviewed some data? On the other hand, a CVwR >30% is not enough to allow reference-scaling for the EMA (“sound clinical justification that a wider difference in Cmax is clinically irrelevant”). Given what’s stated in the guidance the EMA does not consider capecitabine a “critical dose” drug any more.
BTW, this is a Canadian term. Generally the EMA uses NTID (narrow therapeutic index drug) instead.
❝ Old guidance:
❝ Widening of the usual acceptance criteria for Cmax is not accepted because capecitabine is considered a “critical dose” drug.
and
As drug variability has not been reviewed, this guidance is not applicable to highly variables drugs.
❝ Is something changed in the minds of PKWP members? 
Maybe in the meantime they reviewed some data? On the other hand, a CVwR >30% is not enough to allow reference-scaling for the EMA (“sound clinical justification that a wider difference in Cmax is clinically irrelevant”). Given what’s stated in the guidance the EMA does not consider capecitabine a “critical dose” drug any more.
BTW, this is a Canadian term. Generally the EMA uses NTID (narrow therapeutic index drug) instead.
—
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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
Complete thread:
- EMA: 7 product-specific guidances adopted Helmut 2015-07-07 14:10 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: 7 product-specific guidances adopted mittyri 2015-07-08 13:55
- capecitabine ≠ NTID; reference-scalingHelmut 2015-07-08 14:59
- Tadalafil: Similar technology and formulas as the originator luvblooms 2015-07-10 07:24
- Tadalafil: Similar technology and formulas as the originator mmw 2015-07-17 11:38
- 9 new just published Ohlbe 2016-04-07 19:08
- Five new drafts published Helmut 2016-08-23 15:09
- New product specific guidance of Fidaxomicin Mahesh M 2016-08-24 05:58
- EMA: 7 product-specific guidances adopted (Capecitabine) Mauricio Sampaio 2016-12-12 19:33
- Capecitabine: study with healthy volunteers mittyri 2016-12-14 12:39
- EMA: 7 product-specific guidances adopted mittyri 2015-07-08 13:55
Ing. Helmut Schütz