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RegisterBE 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.
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.
Complete thread:
- BE between one injection vs multiple injection productsweiguo2122 2024-06-26 20:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE between one injection vs multiple injection products weiguo2122 2024-06-27 15:07
Ing. Helmut Schütz