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What needs to be done in order to assess the Bioequivalence of two
recombinant protein products intended for both s.c. and i.v use (same
formulation)? Would it suffice to compare the Cmax and AUCs following
i.v. administration only, or would it be necessary to look at bioequivalence
following s.c administration as well? In the latter case, would it be
possible (and practical)to assess both routes of administration in 1
study (4 period cross over)or would it make more sense to look at s.c
adinistration in a separate study (in this case would it make sense to
also include a test product i.v. administration treatment period in
addition to the 2 s.c periods). The goal is to get MAA for both s.c and
i.v use.
Thanks
Sinisa
Sinisa Stipanicic, MS Chem.
PLIVA Research Institute Ltd.
Drug Metabolism and Pharmacokinetics (DMPK)
Prilaz baruna Filipovica 25
10000 Zagreb, CROATIA
Phone: +385 1 372 2572
Fax: +385 1 372 1570
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