Bioequivalence and Bioavailability Forum • 5x5-crossover study with 12 subjects

5x5-crossover study with 12 subjects - sequences [Regulatives / Guidelines]

posted by beman – 2012-03-12 16:38 (5219 d 07:48 ago) – Posting: # 8254
Views: 6,844

really fast response, thank you.

To clarify Study-Design:
12 subjects, reason: pilot study,
5x5 crossover, reason: dose proportionality with 5 different treatments
Drop-Out-Handling: maybe 2 additional subjects (12 + 2 = 14 subjects) instead of replacement to save time

According to the EMA-Guideline: +/- 25 % criteria (no CI's and no ANOVA required)

Thanks

Beman

Complete thread:

5x5-crossover study with 12 subjects - sequences beman 2012-03-12 14:23
- 5x5-crossover study with 12 subjects - sequences ElMaestro 2012-03-12 14:55
- 5x5-crossover study with 12 subjects - sequences Dr_Dan 2012-03-12 15:25
  - 5x5-crossover study with 12 subjects - sequencesbeman 2012-03-12 15:38
    - 5x5-crossover study with 12 subjects - sequences Dr_Dan 2012-03-13 10:59
- 5x5-crossover study with 12 subjects - sequences Helmut 2012-03-12 22:31
  - 12 d_labes 2012-03-13 10:32
  - 5x5-crossover study with 12 subjects - sequences ElMaestro 2012-03-13 11:47
    - Questions over questions d_labes 2012-03-13 13:08
      - ok then lemme explain ElMaestro 2012-03-13 13:26
        
        ok then lemme explain d_labes 2012-03-13 15:03
      - Questions over questions ElMaestro 2012-03-13 15:45
    - 5x5-crossover study with 12 subjects - sequences beman 2012-03-13 13:12
  - 5x5-crossover study with 12 subjects - sequences beman 2012-03-13 13:25