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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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Extrahepatic metabolism of propofol in man during the anhepatic phase of orthotopic liver transplantation. Br J Anaesth 1992;68:183e6. [74] Lee MS, Kerns EH. LC/MS applications in drug development. Mass Spectrometry Reviews 1999;18:187e279. [75] Hsieh Y, Korfmacher WA. Increasing speed and throughput when using hplc-ms/ms systems for drug metabolism and pharmacokinetic screening. Current Drug Metabolism 2006; 7:479e89. [76] Yost RA, Enke CG. Selected ion fragmentation with a tandem quadrupole mass spectrometer.

17) is consistent with these concepts. As an example of one extreme, antipyrine is a drug that essentially exhibits no plasma or tissue protein binding [14]. 18) Thus, Eq. 19) The volume of distribution for antipyrine is equal to the aqueous volume of plasma, tissue and red blood cells. 2, total human body water is estimated at 42 L. The reported volume for antipyrine 41 INTRAVENOUS ADMINISTRATION is ~42 L or essentially body water, as predicted by Eq. 19). In contrast, a drug that is highly protein bound and does not penetrate tissue outside the central compartment would have a volume of ~3 to 4 L, similar to the plasma volume.

LC-MS/MS assays are very common. , 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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