? business as usual [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-12-04 16:42 (1546 d 12:15 ago) – Posting: # 20925
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Hi ElMaestro,

❝ I tried to read that answer 10 times now and I am none the wiser. Do they mean "The guideline will deal with BCS-based biowaivers, but it is acknowledged that some countries might not accept those." ??

:-)


My interpretation as well. I expected that (since Japan had/has always a certain way of thinking).

We had that already in ICH E9 of 1998. The draft followed closely the European one of 1993. Japan insisted to have a “global assessment” in the GL. Quote:

In some cases, 'global assessment' variables […] are developed to measure the over­all safety, overall efficacy, and/or overall usefulness of a treatment. This type of variable integrates objective variables and the investigator’s overall impression [sic] about the state or change in the state of the subject […]
Global assessment variables generally have a subjective component. […]


Japanese investigator approaches the volunteer and asks “How do we feel today?”
Volunteer – unsuccessfully – tries to remove a nasal tube: “Hmpfl…”
Investigator turns away (mumbling “well, very very well…”) and ticks  good in the CRF.

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