🈴 business as usual [BE/BA News]
» 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
☑ goodin the CRF.
© Disney and I.N.D.U.C.K.S.
The quality of responses received is directly proportional to the quality of the question asked. 🚮
- ICH M13 Helmut 2019-11-27 19:08 [BE/BA News]
- ICH M13 ElMaestro 2019-11-27 21:42