? business as usual [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-12-04 16:42 (1149 d 07:34 ago) – Posting: # 20925
Views: 4,734

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]
© Disney and I.N.D.U.C.K.S.


Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,477 posts in 4,708 threads, 1,603 registered users;
18 visitors (0 registered, 18 guests [including 11 identified bots]).
Forum time: 00:16 CET (Europe/Vienna)

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5