Bioequivalence and Bioavailability Forum

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

posted by mittyri  – Russia, 2015-07-08 15:55 (3546 d 00:34 ago) – Posting: # 15050
Views: 15,747

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?

Complete thread:

• EMA: 7 product-specific guidances adopted Helmut 2015-07-07 14:10 [BE/BA News] 
  • 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