Safety Pharmacology

We can provide safe pharmacological experiment services using large and small animals species to explore the effects of drugs on central nervous system, respiratory system and cardiovascular system, and to support drug R&D.

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Safety pharmacology mainly studies the adverse effects of drugs on the central nervous system, cardiovascular system, and respiratory system when introduced drugs are in or above the therapeutic range. Follow-up and/or supplementary safety pharmacology research that may be conducted as required should also include observation of the urinary system, autonomic nervous system, digestive system, and other organs and tissues.

The purpose and significance of safety pharmacology research lies in discovering the undesirable pharmacological effects that may be related to clinical safety, evaluating the adverse reactions or pathological effects observed in toxicological tests or clinical research, and exploring the mechanism of adverse reactions.

Content

Core combination experiment: spontaneous activity, functional observation combination (FOB), whole body plethysmography and telemetryhERG experiment

Test Types

Animals

Drug Types

Route of Administration

Research Content

Safety Pharmacology

Mice, rats;

guinea pigs;

rabbits and beagles.

Micromolecule drugs;

bio-tech-based drugs;

natural drugs;

vaccines;

and traditional Chinese medicine.

Oral administration: intragastric administration and capsule;

Parenteral administration: intraperitoneal injection, intravenous injection, intramuscular injection, intradermal injection, subcutaneous injection, continuous infusion and intravitreal injection;

Other administration: nasal feeding, nasal cavity and eyes;

rectal administration, vaginal administration, implantation, and inhalation.

Cardiovascular system (anesthetized animals/conscious animals);

Central nervous system: spontaneous activity test in mice;

Cardiovascular system: blood pressure, ECG and heart rate test before and after administration;

Respiratory system: respiratory frequency and depth test before and after administration;

Supplementary test.

Experiment solution

Spontaneous activity tester for mice The tester is used in the pharmacological evaluation of central nervous system safety in mice The spontaneous activity of five mice is assessed each time. Digital physiological signal telemetry systemThe system is used to evaluate the effects of drugs on the cardiovascular and respiratory systems of large animals. It features a full digital telemetry system, and concurrently collects the ECG, blood pressure, and respiratory signals of animals, with good signal quality, as well as fast and accurate data analysis. Whole body plethysmography system The system is used to evaluate the effects of drugs on the respiratory system of rats and mice. Eight rats can be tested at one time, while testing respiratory frequency, tidal volume, and minute ventilation. Electrophysiological platform The platform is used for the hERG electrophysiological patch clamp test:

System:	Manual patch clamp
Cell:	HEK293 cells stably transfected with hERG current
Parameter:	Whole cell hERG potassium channel tail current
Concentration:	Five concentrations (IC50)
Repeat data points under each concentration:	N≥3 (on different cells)
Positive control:	Terfenadine or Amitriptyline hydrochloride

If IC50 test is not required in preliminary selection, one or two concentrations can be tested.

Historical positive data

Safety pharmacology mainly studies the potential undesirable adverse effects of drugs on physiological functions when they are in or above the therapeutic range, observing the effects of drugs on central nervous, cardiovascular, and respiratory systems. Follow-up and/or supplementary safety pharmacology research shall be conducted as required.
Follow-up Safety Pharmacology StudiesAny follow-up safety pharmacology study expects possible adverse reactions according to the pharmacological action and chemical structure of the drug. If there are doubts about the results of existing animal and/or clinical trials, and such results may affect human safety, follow-up safety pharmacology studies should be conducted, with in-depth research into the central nervous, cardiovascular, and respiratory systems Supplemental Safety Pharmacology StudiesSupplemental safety pharmacology studies evaluate the effects of drugs on the functions of organs other than the central nervous , cardiovascular or respiratory systems, including the urinary system, autonomic nervous system, gastrointestinal system, and other organs and tissues
The research objectives of safety pharmacology include the following :Determination of the undesirable pharmacological effects of drugs related to human safety;Evaluation of the adverse drug reactions and/or pathophysiological effects observed in toxicology and/or clinical research; Research into the mechanism of observed and/or speculated adverse drug reactions

Safety Pharmacology Platform

Safety Pharmacology of Cell & Gene Therapy Drugs
Potential undesired effects of the study drug on physiological function at doses within or above the therapeutic rangeGenerally include effects on the central nervous system, cardiovascular system, and respiratory systemEffects on other organ systems may need to be assessed depending on product characteristics
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