Bioequivalence and Bioavailability Forum

Dear Ram!

❝ Actually this question related to serum analysis. and Sponsor interested, to check if any change from baseline values and treatment values (decrease in values or not)?

❝ They ask me to calculate maximum decrease in serum concentration (somewhere middle of sampling hour this value comes) and time of max. decrease.

I'm still not sure whether I do understand the problem. You are expecting that administering an endogenous compound to decrease serum levels? Which drug are you talking about? Or are you administering drug A (which you can't measure) and looking on it's effect on endogenous compound B?

❝ I don't have data but following are expected data values.

❝ e.g. for subj 1

❝ time point:            0    2    4    6    8   10   12   14   16   18   20

❝ serum concentration:  20.6 16.5 14.2 10.8  7.3  5.6  9.7 12.9 15.3 18.4 21.5

Are these endogenous levels (a 'normal' profile) or already ones expecting after administration? I would suggest to treat the data in WinNonlin as pharmacodynamic rather than pharmacokinetic ones (NCA Model 220 instead of NCA Models 200-212). Just give it a try.

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