Safety pharmacology and pharmacodynamics (PD) studies are defined in ICH S7A. The core of safety pharmacology studies includes assessing the effects on the cardiovascular, central nervous, and respiratory systems, which should generally be conducted in preclinical settings in accordance with ICH S7A and S7B. If necessary, supplemental and follow-up safety pharmacology studies may be conducted during later stages of clinical development. Any in vivo evaluations should be considered as a complement to general toxicity studies, where feasible, to reduce animal usage.

In addition, primary pharmacodynamics (PD) studies (in vivo and/or in vitro) are designed to investigate the modes of action and/or effects of a substance related to its intended therapeutic targets. These studies are typically conducted during the drug development phase and do not usually adhere to Good Laboratory Practices (GLP). They contribute to dose selection for both non-clinical and clinical studies.

We offer safety pharmacology study services, including:

• Respiratory Rate, Tidal Volume, and Minute Volume.
• Functional Observation Battery (FOB) to evaluate effects on animal behavior, locomotion, and coordination.
• Monitoring of animal experiments for systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, electrocardiogram, and body temperature.
• Neurotoxicity assessment in animal studies.
• Evaluation of QT interval prolongation