Bioequivalence and Bioavailability Forum

How to deal with a sequence effect? [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2008-08-10 16:25 (6519 d 03:23 ago) – Posting: # 2165
Views: 11,499

Dear DLabes!

❝ IMHO:

❝ What you do is to look for differences (and explanations for it) which you consider in your first test (the bioequivalence test using the 90% CIs) as not important enough and not contradictory to the equivalence hypothesis.

Isn’t the null-hypothesis inequivalence?

❝ This is illogical to me.

As already said, it’s not that simple in an interaction study, since clearance may be affected. See EMEA’s guideline on drug interactions (Section 5.1.1):

In most in vivo pharmacokinetic studies it seems reasonable to focus on the exposure of the drug, AUC and the two variables determining this, i.e. extent of absorption, F, and clearance (CL). Other parameters may also be of importance such as C_max and t_½, especially if the safety issue is dependent on the pharmacological action of the product.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• How to deal with a sequence effect? Frieda 2008-08-01 14:36 
  • How to deal with a sequence effect? ElMaestro 2008-08-01 16:36
    • How to deal with a sequence effect? Frieda 2008-08-06 09:57
  • PK interaction studies Helmut 2008-08-01 18:58
    • PK interaction studies Frieda 2008-08-06 18:35
  • How to deal with a sequence effect? d_labes 2008-08-04 09:23
    • How to deal with a sequence effect? Frieda 2008-08-06 13:49
    • How to deal with a sequence effect?Helmut 2008-08-10 14:25
      • How to deal with a sequence effect? d_labes 2008-08-11 14:50
        • How to deal with a sequence effect? Helmut 2008-08-11 16:33
          • actio est reactio d_labes 2008-08-12 09:55
            • actio est reactio Helmut 2008-08-12 12:36