Question raised by the PMDA [Design Issues]

posted by Ben – 2021-03-19 16:47 (1165 d 04:14 ago) – Posting: # 22275
Views: 1,663

Hi Helmut

❝ Based on the agency’s question, what do they require in such a study?

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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