Bioequivalence and Bioavailability Forum

capecitabine ≠ NTID; reference-scaling [BE/BA News]

posted by Helmut  – Vienna, Austria, 2015-07-08 16:59 (3207 d 01:16 ago) – Posting: # 15052
Views: 14,877

Hi Mittyri,

❝ 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 CV_wR >30% is not enough to allow reference-scaling for the EMA (“sound clinical justification that a wider difference in C_max 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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

Complete thread:

• EMA: 7 product-specific guidances adopted Helmut 2015-07-07 14:10 
  • 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