Safety Pharmacology Society - safetypharmacology 2025

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The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drugs adverse effects using continuously evolving methodology.
Using a variety of in vivo and in vitro experimental models, safety pharmacologists carefully design and execute tightly controlled studies to evaluate or predict the harmful and beneficial effects of existing drugs, new drugs, chemicals, or biotechnology-derived entities on humans.
The goal is to generate new knowledge and tools that can lead to better treatments for devastating human medical problems including cancer, addiction, cardiovascular disease, obesity, and infectious disease.
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Safety pharmacology - Current and emerging concepts The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal.
For the purpose of this document, 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.

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