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

posted by weiguo2122 – 2024-06-26 22:17 (21 d 05:24 ago) – Posting: # 24040
Views: 512

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.

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