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Plasma dose-response relationships

Most immunotoxic responses express a clear dose-response relationship that can be used for human risk assessment. However, it is more difficult to extrapolate in vitro concentrations than in vivo animal doses (plasma concentrations) to the clinical dose. [Pg.583]

Ideal for studying the dose-response relationship for QT interval prolongation taking into account all the pharmacological properties of a compound The dog model is one of the most widely used anesthetized rabbits (especially female rabbits) have also been proposed for high sensitivity It provides complementary information with respect to in vitro tests (activity of metabolites, measurement of plasma drug concentrations, calculation of the volume of distribution) Possibility to induce experimental TdP... [Pg.64]

The pharmacokinetics of stimulants are characterized by rapid absorption, low plasma protein binding, and quick extracellular metabolism (Patrick et al., 1987). Although some investigators claim that the dose-response relationship is affected by the child s weight, others have shown that individual dose-response stimulant effects are independent of the child s weight (Rapport et al., 1989). [Pg.256]

For newer agents, defining the plasma level or dose-response relationship should be a priority to avoid using excessive doses for prolonged periods of time. This information may also be relevant for designing clinical trials using appropriate doses of neuroleptics for comparison trials against novel antipsychotics (i.e., parallel dose-response studies). [Pg.76]

The dose-response relationship between DEF fallout and plasma CHE levels was remarkably consistent, extending over 5 orders of magnitude. The lack of a large decrease of CHE in the birds that rode on the applicator may have been due to impeding the fallout of DEP in the cage by a thick rubberized screen with which we lined the cage to protect the birds (unnecessarily as it turned out) from jostling. [Pg.199]

Pharmacokinetics (PK) can be a major source of variability in the dose response relationship. It manifests itself in interindividual differences in the plasma concentration-time profile of a drug. Factors which lead to variability in the ADME parameters are therefore of importance in understanding overall variability in PK. [Pg.430]

ORNL noted that plasma-ChE values in male rats provided the least variable indicator of the lowest-observed-adverse-effect level (LOAEL) and NOAEL for GA and that there was evidence (based on mean plasma-ChE values) of a dose-response relationship. Therefore, ORNL used that data to determine the LOAEL and NOAEL for ChE inhibition by GA. ORNL considered 56.25 g/kg per day to be the LOAEL because of the significant reduction in plasma-ChE concentrations observed in male rats at this dose (relative to controls and baseline values). Because of the lack of consistent change in plasma- and RBC-AChE values (relative to controls and baseline values), ORNL considered the low dose of 28.13 A[Pg.43]

Distributed pharmacokinetics is characterized not only by spatially dependent concentration profiles but also by dose-response relationships that become spatially dependent. For example, biological responses such as cell kill are often quantified as functions of area under the concentration-vs.-time curve (ALIC). In compartment models, response is frequently correlated with the area under the plasma-concentration-vs.-time curve, where... [Pg.110]

Used to define dose or plasma level-response relationships... [Pg.279]

An integrated summary and analysis is to be provided on all data that pertain to dose-response or drug candidate plasma concentration-response relationships of effectiveness and thus to contribute to dose selection, dosing interval, and dosage duration. Relevant data from nonclinical and clinical studies should be referenced and, where appropriate, summarized to illustrate further and describe these relationships. Any identified deviations (e.g., nonlinearity of pharmacokinetics, delayed effects, tolerance, enzyme induction) from relatively simple relationships should be discussed. Also, any evidence of differences in the relationships that result from the age, gender, race, disease status, or other factors of the patients should be described. How the potential for these deviations and differences were evaluated, even if no differences were found, should be described. [Pg.403]

Other Systemic Effects. Workers occupationally exposed to carbon disulfide exhibited elevated plasma sodium and chloride levels and decreased erythrocyte potassium and calcium levels (Pines 1982). In animals, increased adrenal weight, hyperplasia of adrenal cortex, and mild hemosiderosis of the spleen have been observed (Cohen et al. 1959). However, the value of these studies is limited by confounding factors, lack of dose-response relationships, and limitations in study design. [Pg.94]


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See also in sourсe #XX -- [ Pg.296 , Pg.297 ]




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