Bioequivalence and Bioavailability Forum • Partial replicate design & ABE for the FDA

Partial replicate design & ABE for the FDA [Design Issues]

posted by nobody – 2017-03-06 14:47 (2933 d 00:18 ago) – Posting: # 17139
Views: 12,084

❝ I asked numerous times here and in Certara’s Extranet why one wants to use a partial replicate design – and never received an answer. :confused:

One guy told me: I'm not going to determine any parameter that is

a - not asked for by authorities
b - might put my product (now or in the furture...) in a bad light compared to reference

In the very beginning of this scaling discussion someone stated (regarding replicate for Reference): "Why should I characterize the REFERENCE product? This should f**ing do the originator!" No joke...

—
Kindest regards, nobody

Complete thread:

Replicate designs VSL 2017-01-31 06:47 [Design Issues]
- Replicate designs: Pros & Cons Helmut 2017-01-31 12:42
  - Replicate designs: Pros & Cons VSL 2017-01-31 14:03
  - Replicate designs: Pros & Cons Balaji 2017-03-04 11:19
    - Partial replicate design & ABE for the FDA Helmut 2017-03-06 11:40
      - Partial replicate design & ABE for the FDAnobody 2017-03-06 13:47
        
        Partial replicate design & ABE for the FDA Helmut 2017-03-06 14:00
        
        Partial replicate design & ABE for the FDA nobody 2017-03-06 14:18
        
        Partial replicate design & ABE for the FDA Helmut 2017-03-06 17:49