EMA: 7 product-specific guidances adopted [BE/BA News]

posted by mittyri – Russia, 2015-07-08 15:55 (3505 d 04:56 ago) – Posting: # 15050
Views: 15,642

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? :-D

Kind regards,
Mittyri

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