Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Design [Regulatives / Guidelines]

posted by Pharma_88 – India, 2020-08-27 18:07 (895 d 16:15 ago) – Posting: # 21893
Views: 6,804

Dear All,

We are thinking to perform steady state BE study for XXX submission where Test product is ER formulation and Reference product is IR formulation. Further, Its HVD product. So, question is whether is this feasible to conduct replicate BE IR vs ER and if yes then what are the parameters for conclusion?

Thanks.

Complete thread:

DesignPharma_88 2020-08-27 16:07 [Regulatives / Guidelines]
- Jurisdiction? Helmut 2020-08-27 17:32
  - Jurisdiction? Pharma_88 2020-08-31 10:26
    - EMA: ABEL for HVD(P)s, PK metrics Helmut 2020-08-31 12:21
      - EMA: ABEL for HVD(P)s, PK metrics Pharma_88 2020-09-08 09:05
        
        EMA: MD PK metrics Helmut 2020-09-08 17:25

Admin contact
22,488 posts in 4,711 threads, 1,605 registered users;
15 visitors (0 registered, 15 guests [including 6 identified bots]).
Forum time: 09:22 CET (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy. Niklaus Wirth

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz