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Risks and benefit evaluation for controlled human infection studies, where healthy volunteers are deliberately exposed to infectious agents to evaluate vaccine efficacy, should be explicit, systematic, thorough, and non-arbitrary. Decision analysis promotes these qualities using four steps: (1) determining explicit criteria and measures for evaluation, (2) identifying alternatives to the study, (3) defining the models used to estimate the measures for each alternative, and (4) running the models to produce the estimates and compare the alternatives. In this paper, we describe how decision analysis might be applied by funders and regulators, as well as by others contemplating the use of novel controlled human infection studies for vaccine development and evaluation. 相似文献
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Makoto Misono 《Molecular Engineering》1993,3(1-3):193-203
First, fundamental properties (structure, acid and redox properties) and advantages of solid polyoxometalate catalysts (catalyst design by acid and redox control, molecularity, unusual reaction field and unique basicity) are explained. Then, the mechanism of alcohol dehydration elucidated by direct observation of reaction intermediates by solid-state NMR and the very high activity of Cs2.5H0.5PW12O40 are described. Finally several industrial applications of polyoxometalate catalysts are briefly introduced placing stress on the role of unique chemical properties of polyoxometalates. 相似文献
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B. Singh 《Biometrical journal. Biometrische Zeitschrift》1993,35(7):823-831
The distribution and moments, of ANOVA estimator of heritability are given under unbalanced random model. These expressions are used to investigate the effect of unbalancedness on the bias and variance/MSE of the estimator and also the validity of certain approximations for its variance, numerically. The computed results reveal that the unbalancedness increases both the bias and variance/MSE of the estimator and the Smith-approximation for the variance of the estimator provides better accuracy. 相似文献
28.
Promotion of indole alkaloid production in Catharanthus roseus cell cultures by rare earth elements 总被引:3,自引:0,他引:3
Production of the indole alkaloids, ajmalicine or catharanthine, in cell suspension cultures of Catharanthus roseus was enhanced by cerium (CeO2 and CeCl3), yttrium (Y2O3) and neodymium (NdCl3). The yield of ajmalicine in these treated-cultures reached 51 mg l–1 (CeO2), 40 mg l–1 (CeCl3), 41 mg l–1 (Y2O3) and 49 mg l–1 (NdCl3) while catharanthine production reached to 36 mg l–1 (CeO2) and 31 mg l–1 (CeCl3). A major portion of increased alkaloids was released into medium in these treatments. But Sm2O3, SmCl3, La2O3, LaCl3, complex of chromium (III)-titanium (IV) and NaSeO4 treatments had little effect on alkaloid production of C. roseus cell cultures. 相似文献
29.
Predictivity of an in vitro model for acute and chronic skin irritation (SkinEthic) applied to the testing of topical vehicles 总被引:2,自引:0,他引:2
A. de Brugerolle de Fraissinette V. Picarles S. Chibout M. Kolopp J. Medina P. Burtin M.E. Ebelin S. Osborne F. K. Mayer A. Spake M. Rosdy B. De Wever R.A. Ettlin A. Cordier 《Cell biology and toxicology》1999,15(2):121-135
An in vitro human reconstructed epidermis model (SkinEthic) used for screening acute and chronic skin irritation potential
was validated against in vivo data from skin tolerability studies. The irritation potential of sodium lauryl sulfate (SLS),
calcipotriol and trans-retinoic acid was investigated. The in vitro epidermis-like model consists of cultures of keratinocytes
from human foreskin on a polycarbonate filter. The modulation of cell viability, the release and gene expression of proinflammatory
cytokines, interleukins 1α and 8, and morphological changes were evaluated during 3 days as endpoints representative for an
inflammatory reaction. The cumulative irritation potential of the topical products was evaluated in a human clinical study
by visual scoring and biophysical measurement of inflammatory skin reaction after repeated 24 h applications over 3 weeks
under Finn chamber patches. All topical products that were nonirritating in the human study were noncytotoxic and did not
induce cytokine expression in the in vitro acute model (day 1 exposure). All irritating controls exhibited specific cell viability
and cytokine patterns, which were predictive of the in vivo human data. The ranking of mild to moderate skin irritation potential
was based on the lack of cytotoxicity and the presence of cytokine patterns including gene expression specific for each irritant,
using the chronic in vitro model (up to 3 days exposure).
The human reconstructed epidermis model SkinEthic was shown to be a reliable preclinical tool predicting the irritation potential
of topical products. Moreover, it is a useful model in a two-step tiered strategy for screening acute and chronic irritation
potential for the selection of vehicles for new topical drugs.
This revised version was published online in July 2006 with corrections to the Cover Date. 相似文献
30.
Distribution of Ankyrin Isoforms and Their Proteolysis After Ischemia and Reperfusion in Rat Brain 总被引:1,自引:0,他引:1
Kazuki Harada Shiro Fukuda †Manabu Kunimoto Ken-ichi Yoshida 《Journal of neurochemistry》1997,69(1):371-376
Abstract: The distribution of brain-type ankyrin (ankyrinB , 212 kDa) and erythrocyte-type ankyrin (ankyrinR , 239 kDa) was investigated in the subcellular fractions of rat forebrain (P1, 1,000 g pellet; P2, 15,000 g pellet; P3, 100,000 g pellet; S, 100,000 g supernatant) by immunoblotting using specific antibodies. The P2 fraction contained ∼40% of the 212- and 163-kDa isoforms of ankyrinB and the 239-kDa isoform of ankyrinR . Further subfractionation of the P2 by Percoll gradient centrifugation followed by separation of myelin showed association of the three ankyrin isoforms with the synaptosome-rich fraction but not with the myelin-rich fraction. The plasma membrane-rich P3 fraction contained a concentration of ankyrin isoforms similar to that in the P2 fraction. In vitro proteolysis of ankyrin in the P2 fraction with calpain showed that the 212-kDa ankyrinB was more susceptible to calpain than was ankyrinR . In the two-vessel occlusion model, ischemia for 30 min generated the 160-kDa fragment of ankyrinR , and reperfusion for 60 min after 30 min of ischemia remarkably increased the 160-kDa fragment. The reperfusion also significantly decreased the 212-kDa isoform of ankyrinB . Both ischemia-reperfusion and in vitro proteolysis with calpain generated the 160-kDa fragment of ankyrinR , suggesting the involvement of calpain. 相似文献