Question raised by the PMDA [Design Issues]

posted by Ben – 2021-03-19 15:47 (311 d 20:44 ago) – Posting: # 22275
Views: 796

Hi Helmut

» Based on the agency’s question, what do they require in such a study?
  • 90% CI within 80.00–125.00% (all subjects) and
  • additionally the PE of the Japanese sub-group within 80.00–125.00%?

This is what came to my mind.

» Problematic in the Japanese population is the (age-dependent) high percentage of achlorohydric subjects. IIRC, already at an age of 20 years it is about 20% and increases to more than 80% at 60 years.

Oh, this is interesting. I was not aware of this phenomenon. Do you have a reference and/or an explanation why this is the case?

Best regards,

Complete thread:

 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Tuesday 12:31 CET (Europe/Vienna)

I love deadlines.
I love the whooshing sound they make
as they go by.    Douglas Adams

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz