Bioequivalence and Bioavailability Forum

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  

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.

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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.