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By Ali S. Faqi (Auth.)

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

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4). Conceptually, this is correct, but mathematically, the area is estimated by the summation of many trapezoids [7]. 33) The term (t2Àt1) is just the time interval or Dt, and the concentration term [(C2þC1)/2)] is the average concentration during the time interval. 4) where the width of the rectangle is Dt and the length of the rectangle is the average concentration in the time interval. , the dosing interval, all of the trapezoids (or rectangles) under the curve should be summed, as shown in Eq.

Biological Mass Spectrometry 1992;21:517e22. [80] Zhu M, Zhang H, Humphreys WG. Drug metabolite profiling and identification by high-resolution mass spectrometry. J Biol Chem 2011;286:25419e25. [81] Perry RH, Cooks RG, Noll RJ. Orbitrap mass spectrometry: Instrumentation, ion motion and applications. Mass Spectrometry Reviews 2008;27:661e99. [82] Obach RS, Nedderman AN, Smith DA. Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: are they still necessary? Xenobiotica 2012; 42:46e56.

For PK/ TK studies. Validated assays required for GLP toxicology studies as well as clinical studies. INTRAVENOUS ADMINISTRATION Toxicological studies are generally conducted using the targeted route of drug administration in humans, and quite frequently this is PO administration for small molecules and IV administration for biologics. Intravenous administration facilitates a more accurate assessment of clearance values, distribution volumes and half-lives because the availability of the dose is not complicated by the factors limiting absorption (see the 34 3.

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