ICH M13A (IR BE) [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-12-23 10:05 (759 d 23:19 ago) – Posting: # 23409
Views: 7,102

Dear all,

the ICH Draft Guideline Bioequivalence for Immediate-Release Solid Oral Dosage Forms (M13A Step 2) was published yesterday.

Note the new terminology: A – C instead of Tier 1 – 3 mentioned in the Concept Paper.

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
23,363 posts in 4,906 threads, 1,679 registered users;
157 visitors (0 registered, 157 guests [including 14 identified bots]).
Forum time: 09:24 CET (Europe/Vienna)

The combination of some data and an aching desire
for an answer does not ensure that a reasonable answer
can be extracted from a given body of data.    John W. Tukey

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