CV values in BE studies: intra, or inter, or total? [Study As­sess­ment]

posted by Elena777 – Belarus, 2018-01-20 12:31  – Posting: # 18231
Views: 5,994

(edited by Elena777 on 2018-01-20 20:44)

Hello to all.

There is data about CV values (often these values are placed into brackets) in many published reports of BE studies.

I'll provide two examples in order to make my BIG question clear:

1. In a single dose, randomised 3-way cross-over bioequivalence study, comparing the proposed 160 mg product with two reference 160mg tablets from France (Sotalex, Bristol Myers Squibb, France) and Australia (Sotacor, Bristol Myers Squibb, Australia) in healthy adult male volunteers under fasting conditions such results were obtained:

Ln Cmax(ng/ml) for Sotalex-French Reference tablets 160 mg: Mean (CV) = 1212.09 (28.7)

The link to the source: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con2031163.pdf

2. In a another randomized two-dose two-period crossover study on the bioequivalence of oral and intravenous sotalol CV for Cmax (oral route of administration) was 0.41. This value was performed in a separate cell of a table (that table contained data about individual levels of PK parameters of participants, min, max, mean, median as well; you can check it here: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022306s000ClinPharmR.pdf)

The question:

Which kind of CV is performed in my examples? And in general which kind of CV is usually performed in reports of BE studies? Is it CVintra, or CVinter, or CVtotal?


Edit: Please don’t shout! [Helmut]

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