Bioequivalence and Bioavailability Forum

CFDA: seemingly like the EMA [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2017-07-24 20:47 (3259 d 04:59 ago) – Posting: # 17601
Views: 17,870

Hi all,

❝ • The GMR-restriction of 80.00–125.00% (mandatory in all other jurisdictions) is not mentioned. Forgotten?

I think they would prefer the word "implied" since most of the contents are just copied from EMA's guideline.

Complete thread:

• CFDA and reference scaling BRB 2017-07-20 15:44 [Regulatives / Guidelines] 
  • CFDA and reference scaling Helmut 2017-07-20 22:09
    • CFDA and reference scaling BRB 2017-07-20 22:33
      • CFDA and reference scaling Shuanghe 2017-07-21 18:09
        • OT: Uplading / attaching files Helmut 2017-07-21 18:25
      • CFDA: seemingly like the EMA Helmut 2017-07-21 19:23
        • CFDA: seemingly like the EMAShuanghe 2017-07-24 18:47
  • CFDA and reference scaling yicaoting 2017-08-22 16:49
    • CFDA and reference scaling Helmut 2017-08-22 16:59
      • CFDA and reference scaling Shuanghe 2017-08-29 13:12
        • CFDA and reference scaling yicaoting 2017-08-29 18:51