Pharmacological properties human clinical studies

A full set of studies normally includes short-term and long-term animal studies on chronic effects and potential carcinogenicity, studies on reproductive and developmental toxicity, genotoxicity, kinetics and metabolism, pharmacological properties and special studies depending on the characteristics of the substance and observation in the standard set of studies. Human clinical studies may be necessary for substances which are metabolised and may interfere with functions of the human body. 

The objectives of safety pharmacology studies are (1) to identify undesirable pharmacodynamic properties of a substance that may have relevance to its human safety (2) to evaluate adverse pharmacodynamic and/or pathophysiological effects of a substance observed in toxicology and/or clinical studies and (3) to investigate the mechanism of the adverse pharmacodynamic effects observed and/or suspected. 

A great many alkaloids have been found to possess uterine stimulating properties. It is unfortunate that so few of them are therapeutically useful drugs. However, those that are clinically important are very effective d ugs and, when employed judiciously, are extremely valuable therapeutic agents. The usefulness of a drug is determined by manj factors, such as, the rate of its absorption and elimination its diffusibility the rapidity and persistence of its action its side effects and therapeutic index. Tftese aspects of its pharmacology can only be studied, of course, in the intact animal, and preferably in the human subject. In this connection, it should be pointed out that the uterine actions of the majority of... 

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