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Hi,
Can anyone point me to appropriate references that discuss
methods for a BA study for an endogenous substance? I
found a few references that don't seem to be widely cited;
Schindel, Fritz, "Consideration of endogenous backgrounds
in pharmacokinetic analyses: a simulation study", Eur. J.
Clin. Pharmacol. (2000) 56: 685-688.
and several papers by A. Marzo. e.g.
A Marzo, "Open Questions on BE: some problems and solutions"
Pharmacological Research (1999) Vol 40, No 4, 1043.
There is another from 1995 and another, that I don't have, from
1993.
Another paper concerned with this issue used a "subtracted baseline"
analysis method:
Togawa, et al, "A comparison of the BE of two formulations of
epoetin alpha after subcutaneous injection" (2004) Br. J. Clin.
Pharmacology 58:3, 269.
My interest is in learning whether it would be appropriate for a
BA study to be based on a non-linear regression analysis similar
to that described in the Schindel paper?
Thanks,
Paul Robertson
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Most ELISA techniques for endogenous or exogenous compounds use a 4PL
curve
fit.
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