“Lively” discussions [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-11-28 14:23 (425 d 18:36 ago) – Posting: # 20886
Views: 3,125

Dear Ohlbe,

» Don't you expect some lengthy discussions regarding HVD, two-step design, NTID, fed/fasting/both, supporting data from metabolites and stuff like that ? Aren't these significant differences between both sides of the Atlantic ?

Absolutely. Were main topics at the previous meetings. The discussions were, well, cough, lively.1  :-D

There are more things to sort out: Highest strength (EMA) vs. highest dose (FDA), multiple dose for controlled release (EMA practically2[sup][/sup] always, FDA practically never, HC rarely)…

» Final guideline (Step 4) adopted at the last meeting, according to the press release you linked in your first message.

Yep. Not on the ICH’s website yet.


  1. Harmonization is always a compromise. The EMA tried to convey the message to possess the philo­sopher’s stone in its approaches. IMHO, arrogant and not helpful.
  2. IMHO, this “option” to waive the multiple dose study if the residual AUC beyond the intended dosing interval in the single dose study is <10% is rather hot air. Never ever seen such a case. If someone knows an example, let me know.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,316 posts in 4,446 threads, 1,489 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Wednesday 08:59 CET (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

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