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Santosh,
I don't believe there is a well agreed upon answer to your question.
I have seen both #1 and #2 applied to data with a baseline. There
might be something in one of the FDA guidances, but nothing specific
comes to mind.
The question I have is what are you planning on doing with the data.
Do you even need baseline correction?
pete bonate
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Dear Santosh
1. and 2. Unless you know that the concentration of testosterone
dose not show variation with activity, sleep, food consumption,
stress, (the diurnal variations questioned by our moderator, db), I
don't see that you can simply subtract the baseline testosterone
value to get the concentration due to the administered drug.
3. There may be feedback effects that the body used to regulate
testosterone concentration, as there often are for other hormones.
You'll need to check the literature.
If you need to differentiate between endogenous testosterone and
administered testosterone, you could possibly administer testosterone
containing 13C and/or 2H, and analyze for the heavier mass, though
such an approach would need to be carefully thought through.
Depending on the application for your method, you might be able to
use plasma from females as blank matrix. Using healthy females as
volunteers would likely raise ethical, liability, and subject consent
issues.
Tom
Thomas L. Tarnowski, Ph. D.
Bioanalytical Development
Elan Pharmaceuticals
800 Gateway Blvd.
South San Francisco, CA 94080
thomas.tarnowski.aaa.elan.com
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