Bioequivalence and Bioavailability Forum • EMA: 7 product-specific guidances adopted (Capecitabine)

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

posted by Mauricio Sampaio – Brazil, 2016-12-12 20:33 (3022 d 19:35 ago) – Posting: # 16841
Views: 11,470

❝ Dear all, today the EMA published a new batch of product specific guidances (capecitabine, ..."

To capecitabine, ANVISA recommends strength 150 mg and healthy volunteers. Can I imagine a replicate study (partial or full) assuming a total dose of 450 mg (3x150 mg) to 600 mg (4x150 mg), respectively, to each subject in a short time between the periods (WO ~ 1 hour)? :confused:

Complete thread:

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