Bioequivalence and Bioavailability Forum

Hi BE-proff,

❝ In most Russian BE-studies lab parameters are assessed twice - at the screening and at the end of study.

Not in all?

❝ Then obtained results are compared to each other statistically (depending on type of distribution) and conclusion about statistical significance of changes is done.

❝

❝ Is it worth doing?

That’s crap. Imagine the number of tests performed. At which level of significance do these experts run the test? Multiplicity is a killer. Furthermore:

• Some lab parameters are closely related (say GOT, GPT, γ-GT), others are not (say blood pressure with creatinine)…
  
• Hematocrit (post/pre) will be different since we suck so much blood from the poor subjects. Now what?

See also this post.

❝ I have some doubts because sample size is calculated to show BE of medications.

Yep. Is useless. Save the woods.

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PS: I speak about studies in healthy volunteers. Studies in patients or on biosimilars (immunogenicity…) are another cup of tea.