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Could someone provide me some explanation about
this topic (underlined - [removed in the conversion to plain text - was
from Type 2 and below - db]) from Report C - REPORT ON BIOAVAILABILITY
DOSAGE FORMULATIONS OF DRUGS USED
FOR SYSTEMIC EFFECTS:
There are two main types of combination products:
1. Each drug in the product is chosen to elicit a desired effect. The
effects of each ingredient are
not known to depend on predetermined ratios of concentrations of the
drugs in the serum.
2. The amount of each drug in the product is chosen to elicit a
synergistic effect dependent upon
predetermined ratios of concentrations of the drugs in the serum.
The preceding parameters must be reported and assessed and the
following additional parameters
reported for each subject:
1. The ratios of the concentrations of each drug and/or metabolites at
the tmax as determined for
2. The ratios of the concentrations of the drugs at the last time point
of the most commonly used
dosing interval (i.e., at tX);
The ratios of the AUCtX of the drugs and/or metabolites.
The mean (+/- SD) value for each of these 3 parameters must be reported
for each product.
A figure illustrating the mean ratios of the concentrations of each
drug at each time point must be
provided for both the test and reference products.
Where the mean concentration ratios at tmax and tX or the ratios of
AUCT do not correspond to the
predetermined accepted range of ratios of the reference product, the
manufacturer may be required to
provide additional information.
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Copyright 1995-2010 David W. A. Bourne (firstname.lastname@example.org)