Bioequivalence and Bioavailability Forum • Repeated profiles

Repeated profiles [Surveys]

posted by Helmut – Vienna, Austria, 2010-01-04 14:53 (6001 d 20:03 ago) – Posting: # 4556
Views: 16,354

Dear D. Labes,

thanks for participating!

❝ ❝ replicate design in steady state (i.e., TTRR-RRTT)

❝ ^^^^

Something like this:


saturation phase     T       T     switch over         R       R

saturation phase     R       R     switch over         T       T

pre dose values   profile profile  pre dose values  profile profile

This is my interpretation of EMA’s MR-NfG (Section 4.1.2):

The inter-individual variability of the pharmacokinetic parameters of interest should be compared between the modified and immediate release formulation and the variability of the modified release formulation should not exceed that of the immediate release formulation. It may be valuable to assess the intra-individual variability. This could be achieved by either repeated measurements of the concentration profile at steady state or by performing a single dose study with replicate design.

(my emphasis)

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Complete thread:

Cmin (EU) Helmut 2009-12-21 13:08
- Cmin (EU) ElMaestro 2009-12-22 14:17
  - Terminology issues Helmut 2009-12-22 14:30
    - Philostics ElMaestro 2009-12-27 00:47
      - Philostics Helmut 2009-12-27 02:01
        
        Philostics ElMaestro 2009-12-27 13:28
        
        Philostics Helmut 2009-12-27 15:07
        
        Philostics ElMaestro 2009-12-28 02:46
- Cmin (EU) d_labes 2010-01-04 10:45
  - Repeated profilesHelmut 2010-01-04 13:53
- Cmin-value <LLOQ beman 2010-01-04 15:43
  - Cmin-value <LLOQ Helmut 2010-01-04 16:34