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RegisterEMA: 7 product-specific guidances adopted [BE/BA News]
Hi Helmut&all!
Following up upon our previous discussion about Capectabine.
Old guidance:
Widening of the usual acceptance criteria for Cmax is not accepted because capecitabine is considered a “critical dose” drug.
New guidance:
Since high intra-individual variability (CVintra > 30 %) is expected, the applicants might follow respective guideline recommendations.
Is something changed in the minds of PKWP members?
Following up upon our previous discussion about Capectabine.
Old guidance:
Widening of the usual acceptance criteria for Cmax is not accepted because capecitabine is considered a “critical dose” drug.
New guidance:
Since high intra-individual variability (CVintra > 30 %) is expected, the applicants might follow respective guideline recommendations.
Is something changed in the minds of PKWP members?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- EMA: 7 product-specific guidances adopted Helmut 2015-07-07 14:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: 7 product-specific guidances adoptedmittyri 2015-07-08 13:55
- capecitabine ≠ NTID; reference-scaling Helmut 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 adoptedmittyri 2015-07-08 13:55
Ing. Helmut Schütz