“Lively” discussions [BE/BA News]
❝ 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
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.
- 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.
- 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 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
- ICH M13 Helmut 2019-11-27 19:08
- ICH M13 ElMaestro 2019-11-27 21:42