Question raised by the PMDA [Design Issues]

posted by Ben – 2021-03-19 15:47 (211 d 16:08 ago) – Posting: # 22275
Views: 712

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,

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