Read e-book online A Comprehensive Guide to Toxicology in Preclinical Drug PDF

By Ali S. Faqi (Auth.)

ISBN-10: 0123878152

ISBN-13: 9780123878151

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Extra resources for A Comprehensive Guide to Toxicology in Preclinical Drug Development

Sample text

In the absorption phase after a PO dose, the area under the true PK curve can be underestimated. The extent to which the linear trapezoidal rule is in error depends on the curvature of the PK profile as well as the frequency of sampling time points.

While the equation Vss ¼ MRTIV $Cl (Eq. 11)) is often used to calculate Vss, it should not be assumed that Vss is dependent on or solely determined by these parameters. Thus, both CL and Vd are independent PK parameters. 2, the volume of the beaker (Vd) and the filtration rate (CL) are independent variables and are not dependent on dose or AUC. Although this concept may seem obvious, it is often overlooked or forgotten during routine PK/TK analysis. Half-Life Half-life (t1/2) is defined as the amount of time required for the drug concentration measured in plasma (or other biological matrices) to be reduced to exactly half of its starting concentration or amount.

10 In panel (a), a smooth PK curve consistent with oral administration is presented. In panel (b), the same data points are used to define trapezoids under the curve for each small time interval between blood sampling time points. Qualitatively, the area under the curve is estimated well by a series of trapezoids. Also shown is a truncation of the full PK curve because the plasma collection time points did not extend past 24 hours post-dose. In this case, the remaining area under the curve after the last data point is estimated using Eq.

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A Comprehensive Guide to Toxicology in Preclinical Drug Development by Ali S. Faqi (Auth.)

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