Bioequivalence and Bioavailability Forum

Sequence Effect on Endogenous Drugs [Regulatives / Guidelines]

posted by Lucas – Brazil, 2014-02-11 13:24 (4517 d 07:02 ago) – Posting: # 12394
Views: 10,602

Hello ElMaestro!

❝ Did you observe a period effect (thyroid seasonal variation with 70day washout)?

No, the p-value for period effect was >30%, so not even close to be significant. But, despite that, it seems like the second period baseline level was higher. This chart below is a representation of the ratio between the second period mean baseline and the first period mean baseline.



Seems to me that there is a difference between the two period when it comes to baseline level. That behaviour was not noticed in the other studies.

❝ Did you check if your randomisation was useful?

We did not ran any statistical test for that, but the study finalized with 12 subjects in one sequence and 13 in the other.

Complete thread:

• Sequence Effect on Endogenous Drugs Lucas 2014-02-10 20:01 
  • Sequence Effect on Endogenous Drugs ElMaestro 2014-02-10 20:09
    • Sequence Effect on Endogenous DrugsLucas 2014-02-11 12:24
      • Sequence Effect on Endogenous Drugs ElMaestro 2014-02-11 13:26
        • Sequence Effect on Endogenous Drugs Lucas 2014-02-11 17:38
  • Sequence Effect on Endogenous Drugs jag009 2014-02-10 21:35
    • Sequence Effect on Endogenous Drugs Lucas 2014-02-11 12:28
      • Sequence Effect on Endogenous Drugs jag009 2014-02-11 17:21
        • Sequence Effect on Endogenous Drugs Lucas 2014-02-11 17:33
  • Sequence Effect on Endogenous Drugs Helmut 2014-02-11 15:07
    • Curious jag009 2014-02-11 17:16
    • Sequence Effect on Endogenous Drugs Lucas 2014-02-11 17:45
  • Four studies with the same formulation Lucas 2014-02-11 17:32
    • Four studies with the same formulation jag009 2014-02-11 20:01