General definition

Safety pharmacology studies are defined as those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.

Safety pharmacology studies are generally conducted to investigate those systems contained in the core battery, as defined by the ICH guidelines: central nervous system, respiratory system, cardiovascular system. In a nutshell, it is generally understood that safety pharmacology studies are concerned with undesirable effects that may arise from exposure to a chemical entity at concentrations that approximate the therapeutic range expected from the compound.


Safety Vs toxicology
Toxicology is the study of the adverse effects of chemical, physical or biological agents on living organisms and the ecosystem, including the prevention and amelioration of such adverse effects.

However, in the context of drug development, toxicology is generally regarded as the study of the adverse effects that may arise from exposure to levels or concentrations of a drug, or potential drug, that considerably exceed the therapeutic level anticipated for any given population. These adverse effects may appear following short-term exposure, or may be detectable only following chronic exposure to low or high levels of chemical entity.


In-Vitro or In-Vivo?
Safety pharmacology studies can be conducted both in vivo and in vitro. The advantages of each approach are remarkably complementary; the integrated observations made on whole animals often benefits from the greater sensitivity of the in vitro results. Inversely, the holistic context of in vivo parameters is generally necessary for the adequate and thorough interpretation of data generated on cell lines, tissues, or explanted organs.


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* in progress