Bioequivalence and Bioavailability Forum • Partial vs. sequential tests in WNL

Partial vs. sequential tests in WNL [Software]

posted by zan – US, 2014-07-01 20:03 (3947 d 12:35 ago) – Posting: # 13196
Views: 26,997

❝ I would not bother about #1–8 and rather concentrate on

❝ 9. If ALL of the following criteria are met, it may not be necessary to

❝ include Group-by-Treatment in the statistical model:

❝ ● the clinical study takes place at one site;

❝ ● all study subjects have been recruited from the same enrollment pool,

❝ ● all of the subjects have similar demographics;

❝ ● all enrolled subjects are randomly assigned to treatment groups at study outset.

❝ In this latter case, the appropriate statistical model need include only the factors Sequence, Period, Treatment, and Subject (nested within Sequence).

Hi Helmut,
On page 6 of the document (http://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/077570Orig1s000BioeqR.pdf) we discussed above, reviewer provided the justification why the two dosing groups needed to be separated (looks stringent):

Although the subjects in the study were from the same geographic region and have the same demographic profiles, they were not enrolled in the study at the same time. The subjects enrolled in group 2 were screened after the beginning of the fasting study for group 1. There were 15 days in between the dosing of the two groups.
Therefore, individual statistical analysis is performed for each group.

zan

Complete thread:

Phoenix WNL to handle 2x2 crossover study with multip group zan 2014-06-27 23:29
- Phoenix WNL to handle 2x2 crossover study with multip group ElMaestro 2014-06-28 23:23
- Group effect commonly not relevant Helmut 2014-06-30 16:55
  - Group effect in 2x2 BE study zan 2014-06-30 19:18
    - Group effect in 2x2 BE study ElMaestro 2014-06-30 20:36
    - To pool or not to pool Helmut 2014-06-30 20:51
      - To pool or not to pool zan 2014-06-30 21:02
        
        To pool or not to pool Helmut 2014-06-30 21:38
        
        To pool or not to pool zan 2014-06-30 21:46
        
        To pool or not to pool Helmut 2014-06-30 22:22
        
        To pool or not to pool zan 2014-07-01 01:15
        
        Partial vs. sequential tests in WNL Helmut 2014-07-01 12:26
        
        Partial vs. sequential tests in WNLzan 2014-07-01 18:03
        
        Loosing patience Helmut 2014-07-01 18:23
        
        To pool or not to pool ElMaestro 2014-06-30 22:11
        
        To pool or not to pool zan 2014-07-01 01:18
        To pool or not to pool zan 2014-07-02 19:56
        
        To pool or not to pool ElMaestro 2014-07-03 00:17
        
        To pool or not to pool zan 2014-07-03 00:36
        
        sequence- / period effect #666 Helmut 2014-07-03 10:05
  - Group effect commonly not relevant AngusMcLean 2014-07-06 16:19
    - Group effect commonly not relevant Helmut 2014-07-06 20:32
      - Group effect commonly not relevant AngusMcLean 2014-07-06 22:52
        
        Group effect commonly not relevant Helmut 2014-07-06 23:57
        
        PHX: Parameter mapping AngusMcLean 2014-07-07 15:04
        
        PHX: Parameter mapping Helmut 2014-07-07 15:45
        
        PHX: Parameter mapping Shuanghe 2014-07-07 17:35
        
        Great hint! Helmut 2014-07-07 17:54
        PHX: Parameter mapping AngusMcLean 2014-07-07 20:49
        
        PHX: Parameter mapping AngusMcLean 2014-07-07 18:46