Bioequivalence and Bioavailability Forum • BE between one injection vs multiple injection products

weiguo2122
☆

2024-06-26 22:17
(319 d 23:20 ago)

Posting: # 24040
Views: 2,023

BE between one injection vs multiple injection products [Design Issues]

Hi, Dear all,
A product A currently is injected weekly for 4 weeks as one treatment term, we would have a slowly release product A (slow-A), which will be injected monthly. Then we would like to access the BE of A injected 4 time vs slow-A injected 1 time. How is this type of BE between one injection vs multiple injection conducted?

Cmax?

sum of AUCA1-4 vs AUC_slow-A?

Is there any guidance from FDA or EMA.

Any help is greatly appreciated.

weiguo2122 ☆ 2024-06-27 17:07 (319 d 04:30 ago) @ weiguo2122 Posting: # 24044 Views: 1,598	BE between one injection vs multiple injection products Post reply
	That should not be a BE study? Then what should be considered when we develop product from daily injection to weekly as well as weekly to monthly? Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]