Bioequivalence and Bioavailability Forum • ? business as usual

? business as usual [BE/BA News]

posted by Helmut – Vienna, Austria, 2019-12-04 16:42 (2390 d 18:35 ago) – Posting: # 20925
Views: 10,398

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.

[image]
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Complete thread:

ICH M13 Helmut 2019-11-27 19:08
- ICH M13 ElMaestro 2019-11-27 21:42
  - ICH pushed by GBHI? Helmut 2019-11-28 12:37
    - ICH pushed by GBHI? Ohlbe 2019-11-28 14:06
      - “Lively” discussions Helmut 2019-11-28 14:23
        
        M9 step 4 now published Ohlbe 2019-12-04 11:26
        
        And Japan? Helmut 2019-12-04 11:42
        
        And Japan? ElMaestro 2019-12-04 14:43
        
        ? business as usualHelmut 2019-12-04 15:42