Biologies pharmacological/toxicological assessment

Pharmacological-Toxicological Assessment Section Centre for Biological Medicines and Medical Technology National Institute of Public and Environment... 

Figure 7.4 Typical frequency distribution of a population response to an equivalent dose of a biologically active agent. This type of response represents the variability that occurs within biological systems and is the basis for the concept of dose response in pharmacology and toxicology. This figure demonstrates that within any population, both hyporeactive and hyperreactive individuals can be expected to exist and must be addressed in a risk assessment.

In the context of safety pharmacology, measurement of hypothalamic hormone concentrations is performed in the context of repeated dose treatment, to assess changes after a several days period of biological adaptation. These measurements can be added to any of the conventional subacute toxicology protocols. 

The synthesis protocols shown in Schemes 15—19 afforded access to 10—100 mg quantities of some of the procyanidins shown, permitting assessment of their in vitro biological activities. " With a view to fully develop the potential clinical applications for this class of compounds, and to address pharmacological and toxicological requirements, Romanczyk and coworkers recently reported the process scale-up conditions required for the multigram synthesis of procyanidin B-1 (90) and the 3,3-di-O-gallate (98) of procyanidin B-2... 

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