Question raised by the PMDA [Design Issues]
❝ 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?