By Ali S. Faqi (Auth.)
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36)) is used in the final extrapolation to infinity where data have not been collected. 42) In practice, AUC is routinely calculated with commercial PK software and several variants of the trapezoidal rule are possible [7,15]. 10), which connects adjacent plasma concentration data points with a linear line and the area under the curve is then approximated by the area of a trapezoid. This method is well known and widely used; however, the reader should be aware that there are several conditions under which it is prone to error.
Clearance can occur in blood, liver, kidneys, at the site of injection, or by receptor-mediated clearance. Wide range of distribution volumes possible. Volume of distribution is usually small, and limited to plasma and/ or extracellular fluids for monoclonal antibodies. The smaller the protein, the larger the volume of distribution. Partitioning into blood cells is possible but not particularly common. Partitioning into blood cells is not a concern. Metabolism can be quite complex, and because both active and non-active metabolites can be formed, they must be characterized for IND/NDA work.
However, there is at least one example where active tissue uptake and binding to intra- and extravascular proteins substantially increases the apparent volumes of distribution. This example is atrial natriuretic peptide which has a reported Vss of ~12 L and a Vz of 32 L . Finally, it should be noted that Vss is also considered to be an independent PK parameter . Similar to the discussion for CL, this implies that Vss can be determined independently of other PK parameters, and directly reflects in vivo physiological (steady state distribution) mechanisms.
A Comprehensive Guide to Toxicology in Preclinical Drug Development by Ali S. Faqi (Auth.)