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Dear All,
If i want to register a new strength of a drug, how
to compare
the bioavailability of it
with a standard strength. For example, the new strength is 30mg and
standard is 20 mg. Is it
possible to do this experiment ?
Regards
Daniel
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Hi Daniel,
One suggestion can be 2 x 30mg versus 3 x 20 mg.
If the pharmacokinetics of the drug is linear than use the one dosage
unit from each formulation and than performed a dose-adjustment before
the statistical analysis of the data.
radu
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