Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Selection of the animal species

Topical formulations are another special case. Over time, it has been shown that the minipig has a skin structure that is quite similar to humans, and that species is now used commonly as the nonrodent model. These types of formulations also require local irritation studies where guinea pigs are used to determine delayed contact sensitization. Selection of the animal species for the nonclinical program is often not straightforward. [Pg.296]

For testing pharmaceuticals, two animal species are required, one rodent and one non-rodent species, usually the rat and the dog. The decision on the selection of the animal species is based on the kinetic and metabolic characteristics of the drug substance. [Pg.781]

In the early stages of preclinical development, metabolite profiling is performed using in vitro systems from animal and human, mainly to identify potential species-dependent metabolism early in the development process and to support the selection of the animal species employed in safety assessment studies. As the compound moves further into development, in vivo animal ADME studies are performed. The compound is usually dosed into a rodent and nonrodent species along with an efficacy model. Metabolism data from the animal studies are then used in species selection for safety assessment to insure that all expected human metabolic transformations will be represented in the animal models used in the safety study. [Pg.337]

Biological activity can be evaluated by using in vitro techniques to determine which effects of the product are related to clinical activity. Due to species specificity of biotechnology derived products, it is necessary to select relevant species for testing. Mammalian cell lines can be used to predict in vivo activity and the relative sensitivity of various species including man. Such studies are useful to determine receptor occupancy, receptor affinity pharmacological aspects, and for the selection of adequate animal species for toxicity testing. [Pg.799]

Toxicity is the outcome of interaction between a chemical and a living organism. The toxicity of any chemical depends on its own properties and on the operation of certain physiological and biochemical processes within the animal or plant that is exposed to it. These processes are the subject of the present chapter. They can operate in different ways and at different rates in different species—the main reasons for the selective toxicity of chemicals between species. On the same grounds, chemicals show selective toxicity (henceforward simply selectivity ) between groups of organisms (e.g., animals versus plants and invertebrates versus vertebrates) and also between sexes, strains, and age groups of the same species. [Pg.18]

In the absence of information to demonstrate that such a selection is incorrect, data from the animal species, strain, and sex showing the greatest sensitivity to a chemical s toxic properties will be selected as the basis for human risk assessment. [Pg.229]

The animal species chosen for the later nonclinical safety studies should be responsive to the pharmacodynamic action(s). If the standard laboratory species are not responsive, the applicant should justify the choice of species selected or any supplementary tests if these are deemed appropriate. [Pg.492]


See other pages where Selection of the animal species is mentioned: [Pg.478]    [Pg.66]    [Pg.276]    [Pg.58]    [Pg.478]    [Pg.66]    [Pg.276]    [Pg.58]    [Pg.655]    [Pg.382]    [Pg.302]    [Pg.37]    [Pg.204]    [Pg.277]    [Pg.545]    [Pg.727]    [Pg.729]    [Pg.738]    [Pg.770]    [Pg.128]    [Pg.619]    [Pg.275]    [Pg.34]    [Pg.35]    [Pg.127]    [Pg.109]    [Pg.18]    [Pg.24]    [Pg.691]    [Pg.528]    [Pg.603]    [Pg.1688]    [Pg.351]    [Pg.4]    [Pg.66]    [Pg.447]    [Pg.698]    [Pg.76]    [Pg.200]    [Pg.124]    [Pg.14]    [Pg.112]    [Pg.61]    [Pg.115]    [Pg.493]    [Pg.571]    [Pg.119]   
See also in sourсe #XX -- [ Pg.781 ]




SEARCH



Animal selection

Selection of animal species

Species selectivity

The Animal

© 2024 chempedia.info