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2 The number of live births, relative to the number of total births 3 Pre-implantation loss, or number of corpora lutea in the ovaries relative to the number of implantation sites 4 Postimplantation loss, or the number of resorption sites in the uterus relative to the number of implantation sites 5 Duration of gestation 6 Effects on male or female reproductive systems 7 Litter size and condition, gross morphology of pups at birth, gender, and anogenital distance 8 Survival of pups 9 Weight gain and performance of adults and pups 10 Time of occurrence of developmental landmarks, such as eye opening, tooth eruption, vaginal opening in females, preputial separation in males 11 Morphological abnormalities in weanlings Results from single and multiple generation tests provide important information for assessment of test materials that may perturb a variety of systems including the endocrine system.

as a function of j; k; x, and t. The state information at time 0 is the pair j; x . Let P be the transition matrix of the discrete-time Markov chain governing level transitions and let Fjk t be the holding-time cdf given that there is a transition from level j to c level k. For simplicity, we assume that Fjk t 1 Fjk t > 0 for all j; k, and t, so that all positive x can be level holding times. Let P tjx be the matrix with elements ^ Pjk tjx and let P sjx be the Laplace transform (LT) of P tjx , that is, the matrix with elements that are the Laplace transforms of Pjk tjx with respect to time: ^ Pjk sjx I

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A number of variations of the single and multiple generation tests exist For example, a number of weanlings may be left to develop and be tested later for behavioral and/or physiological defects (eg, developmental neurotoxicity testing)..

The clinical and immunologic impact of using interferon and ribavirin in the immunosuppressed host Liver Transplant 2003, 9, S79 S89 39 Tam, R C; Pai, B; Bard, J; Lim, C; Averett, D R; Phan, U T; Milovanovic, T Ribavirin polarizes human T cell responses towards a Type 1 cytokine pro le J Hepatol 1999, 30, 376 382 40 Hultgren, C; Milich, D R; Weiland, O; Sallberg, M The antiviral compound ribavirin modulates the T helper (Th)1/Th2 subset balance in hepatitis B and C virus-speci c immune responses J Gen Virol 1998, 79, 2381 2391 41 Smee, D F; Bailey, K W; Sidwell, R W Treatment of cowpox virus respiratory infections in mice with ribavirin as a single agent or followed sequentially by cidofovir Antiviral Chem Chemother 2000, 11, 303 309..

e st Pjk tjx dt:

Teratology. Teratology is the study of abnormal fetal development. For an agent to be labeled a teratogen, it must signi cantly increase the occurrence of adverse structural or functional abnormalities in offspring after its administration to the female during pregnancy or directly to the developing organism. In teratology testing, exposure to the test chemical may be from implantation to parturition, although it has also been restricted to the period of major organogenesis, the most sensitive period for inducing structural malformations. Observations may be extended throughout life, but usually they are made immediately prior to birth after a C-section. The end points observed are mainly morphologic (structural changes and malformations), although embryofetal mortality is also used as an end point. Figure 21.4 shows an outline of a typical teratology study. Teratology studies are carried out in two species, a rodent species (usually the rat) and in another species such as the rabbit (rarely in the dog or primate). Enough females

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42 Heagy, W; Crumpacker, C; Lopez, P A; Finberg, R W Inhibition of immune functions by antiviral drugs J Clin Invest 1991, 87, 1916 1924 43 Pankiewicz, K W Inhibitors of inosine monophosphate dehydrogenase as potential chemotherapeutic agents Exp Opin Ther Patents 1999, 9, 55 65 44 Sidwell, R W; Huffman, J H; Barnett, B B; Pifat, D Y In vitro and in vivo Phlebovirus inhibition by ribavirin Antimicrob Agents Chemother 1988, 32, 331 336 45 Watts, D M; Ussery, M A; Nash, D; Peters, C J Inhibition of Crimean-Congo hemorrhagic-fever viral infectivity yields in vitro by ribavirin Am J Trop Med Hyg 1989, 41, 581 585 46 Koff, W C; Elm, J L; Halstead, S B Antiviral effects of ribavirin and 6-mercapto-9tetrahydro-2-furylpurine against dengue viruses in vitro Antiviral Res 1982, 2, 69 79 47 Morrey, J D.

Teratology Gestation Untreated females Mating Untreated males Pregnant females treated on days 6-15. Pups and dams sacrificed day 20

^ We can obtain a convenient explicit expression for P sjx . For this purpose, let Gj be the holding-time cdf in level j, unconditional on the next level, that is, Gj x P

Pjk Fjk x :

Perinatal/Postnatal Gestation Untreated females Mating Untreated males Pregnant females treated on days 15-21 Lactation Females treated to weaning. Pups and dams sacrificed at weaning

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