Question raised by the PMDA [Design Issues]

posted by Ben – 2021-03-19 15:47 (135 d 15:42 ago) – Posting: # 22275
Views: 576

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,
Ben.

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time: Monday 08:29 CEST (Europe/Vienna)

Imagine if every Thursday your shoes exploded
if you tied them the usual way.
This happens to us all the time with computers,
and nobody thinks of complaining.    Jef Raskin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5