Bioequivalence and Bioavailability Forum • Population BE for in-vitro data

Population BE for in-vitro data [Regulatives / Guidelines]

posted by krishna – India, 2013-06-19 14:03 (4760 d 03:35 ago) – Posting: # 10815
Views: 5,271
(edited on 2013-06-20 08:46)

❝ As per the above FDA guidline for in-vitro PBE, it was mentioned (page no. 4) that point estiamate should fall in (90 - 111). But from the recent Budesonide suspension OGD guidance http://www.fda.gov/downloads/Drugs/.../Guidances/UCM319977.pdf, there is no such criteria except the 95% Upper bound < =0. What is the rationale behind this, can any body clarify me? As per my understanding, point estimate criteria drive the results in a good way like scaled average bio equivalence. Correct me if I am wrong.

Hi all,

As per my knowledge, point estimate criteria prevents not to shift the mean ratio too far from 1.

Thanks,

Krishna.

Complete thread:

Population BE for in-vitro data Ankita 2011-06-24 15:32
- Critical value d_labes 2011-06-29 09:07
  - Critical value Ankita 2011-06-30 19:06
- Population BE for in-vitro data krishna 2013-06-18 14:01
  - Population BE for in-vitro datakrishna 2013-06-19 12:03
    - Population BE for in-vitro data Helmut 2013-06-19 18:24