Bioequivalence and Bioavailability Forum • Sequence Effect on Endogenous Drugs

Sequence Effect on Endogenous Drugs [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2014-02-10 21:09 (4521 d 16:33 ago) – Posting: # 12390
Views: 10,728

Hi Lucas,

❝ We conducted a crossover 2x2 study of Levothyroxine 65ug and found a significant sequence effect (considering a significance level of 10%). According to ANVISA guidelines, a siginifcant sequence effect can only be desconsiderd if (...)

This isn't sounding good. Before writing it off, I'd look at the data production. Did you observe a period effect (thyroid seasonal variation with 70day washout)? Did you check if your randomisation was useful?

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Pass or fail!
ElMaestro

Complete thread:

Sequence Effect on Endogenous Drugs Lucas 2014-02-10 20:01
- Sequence Effect on Endogenous DrugsElMaestro 2014-02-10 20:09
  - Sequence Effect on Endogenous Drugs Lucas 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