Bioequivalence and Bioavailability Forum

Add-on designs obsolete! [Two-Stage / GS Designs]

posted by jag009  – NJ, 2014-06-18 18:04 (4022 d 13:03 ago) – Posting: # 13082
Views: 5,985

Hi Helmut!

❝ It was shown in numerous publi­cations that the patient’s risk will be inflated (i.e., >5%) by this method. Therefore, HC/HPFB/TGD abandoned it in 2012.

Can you point me to some of those publications? I wasn't "born" yet back then so I would gain some knowledge.

❝ The only regulation where Add-on designs are still acceptable is the Japanese.

This is surprising since the Japanese are so strict on quality. When I was visiting Japan, I noticed that their groceries (packaged items) have very short expiry dates (like 2 weeks)...

Thanks
John

Complete thread:

• Add-on and Two-Stage Designs Mahesh M 2014-06-17 11:12 
  • Add-on designs obsolete! Helmut 2014-06-17 13:36
    • Add-on designs obsolete! Mahesh M 2014-06-18 06:38
    • Add-on designs obsolete!jag009 2014-06-18 16:04
      • Add-on designs obsolete! Helmut 2014-06-18 19:41