“Lively” discussions [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-11-28 14:23 (905 d 16:02 ago) – Posting: # 20886
Views: 4,535

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 🖖 [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
22,091 posts in 4,630 threads, 1,566 registered users;
online 10 (0 registered, 10 guests [including 5 identified bots]).
Forum time: Sunday 07:25 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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