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Toxicokinetics and Metabolism Routine toxicity testing without regard to the mechanisms involved is likely to be wasteful of time and of human, animal, and nancial resources A knowledge of toxicokinetics and metabolism can give valuable insights and provide for testing that is both more ef cient and more informative Such knowledge provides the necessary background to make the most appropriate selection of test animal species and of dose levels, and the most appropriate method for extrapolating from animal studies to the assessment of human hazard Moreover they may provide information on possible reactive intermediates as well as information on induction or inhibition of the enzymes of xenobiotic metabolism, the latter being critical to an assessment of possible interaction The nature of metabolic reactions and their variations between species is detailed in s 7, 8, and 9 with some aspects of toxicokinetics in 6.

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where j j1 ; . . . ; jn is the vector of levels and x x1 ; . . . ; xn is the vector of elapsed holding times for the n sources with the single-source means and variances as in Eqs. (17.19) and (17.21). It is signi cant that we can calculate the conditional aggregate mean at any time t by performing a single numerical inversion, for example, by using the Euler algorithm in Abate and Whitt [2]. We summarize this elementary but important consequence as a theorem. Theorem 17.4.2. The Laplace transform of the n-source conditional mean aggregate required bandwidth as a function of time is ^ M sjj; x I

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The methods used for the measurement of toxicants and their metabolites are detailed in 25 The present section is concerned with the general principles, use, and need for metabolic and toxicokinetics studies in toxicity testing Toxicokinetics studies are designed to measure the amount and rate of the absorption, distribution, metabolism, and excretion of a xenobiotic These data are used to construct predictive mathematical models so that the distribution and excretion of other doses can be simulated Such studies are carried out using radiolabeled compounds to facilitate measurement and total recovery of the administered dose This can be done entirely in vivo by measuring levels in blood, expired air, feces, and urine; these procedures can be done relatively noninvasively and continuously in the same animal Tissue levels can be measured by sequential killing and analysis of organ levels.

controlled clinical trial of intravenous ribavirin therapy of hemorrhagic fever with renal syndrome J Infect Dis 1991, 164, 1119 1127 Chapman, L E; Mertz, G J; Peters, C J; Jolson, H M; Khan, A S; Ksiazek, T G; Koster, F T; Baum, K F; Rollin, P E; Pavia, A T; Holman, R C; Christenson, J C; Rubin, P J; Behrman, R E; Bell, L J W; Simpson, G L; Sadek, R F Intravenous ribavirin for hantavirus pulmonary syndrome: safety and tolerance during 1 year of open-label experience Antiviral Ther 1999, 4, 211 219 Mertz, G J ; Miedzinski, L; Goade, D; Pavia, A T; Hjelle, B; Hansbarger, C O; Levy, H; Koster, F T; Baum, K; Lindemulder, A; Wang, W Q; Riser, L.

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It is important to measure not only the compound administered but also its metabolites, because simple radioactivity counting does not differentiate among them The metabolic study, considered separately, consists of treatment of the animal with the radiolabeled compound followed by chemical analysis of all metabolites formed in vivo and excreted via the lungs, kidneys, or bile Although reactive intermediates are unlikely to be isolated, the chemical structure of the end products may provide vital clues to the nature of the intermediates involved in their formation The use of tissue homogenates, subcellular fractions, and puri ed enzymes may serve to clarify events occurring during metabolic sequences leading to the end products Information of importance in test animal selection is the similarity in toxicodynamics and metabolism to that of humans.

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; Fernandez, H; Whitley, R J Placebo-controlled, double blind trial of intravenous ribavirin for hantavirus cardiopulmonary syndrome in North America Clin Infect Dis, 2004, 39, 1307 1313 Chong, H T; Kamarulzaman, A; Tan, C T; Goh, K J; Thayaparan, T; Kunjapan, R; Chew, N K; Chua, K B; Lam, S K Treatment of acute Nipah encephalitis with ribavirin Ann Neurol 2001, 49, 810 813 Goldstein, B M; Colby, T D IMP dehydrogenase: structural aspects of inhibitor binding Curr Med Chem 1999, 6, 519 536 Markland, W; McQuaid, T J; Jain, J; Kwong, A D Broad-spectrum antiviral activity of the IMP dehydrogenase inhibitor VX-497: a comparison with ribavirin and demonstration of antiviral additivity with alpha interferon Antimicrob Agents Chemother 2000, 44, 859 866 Canonico, P G; Jahrling, P B; Pannier, W L.

Although all of the necessary information may not be available for humans, it can often be inferred with reference to metabolism and excretion of related compounds, but it is clearly ill advised to use an animal that differs from most others in the toxicokinetics or metabolism of the compound in question or that differs from humans in the nature of the end products Dose selection.

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