With over 30 years of experience in new drug research and preclinical safety pharmacology evaluation, Joinn Pharma has built a stable, professional and highly experienced safety pharmacology team capable of providing comprehensive safety pharmacology evaluation services for clients. All study designs are conducted in strict accordance with international preclinical safety evaluation guidelines including ICH S7A/S7B, NMPA regulations, and laboratory animal management standards.
Conscious unrestrained animal test (dogs, miniature pigs, non-human primates)
ECG and hemodynamic tests in anesthetized animals (dogs, non-human primates)
Langendorff isolated heart function test
Patch-clamp: hERG assay
Conscious unrestrained animal test (dogs, non-human primates): respiratory rate, tidal volume, minute ventilation
Rodents (WBP mode): respiratory rate, tidal volume, minute ventilation.
Irwin’s test, FOB (mice, rats, dogs, cynomolgus monkeys)
Spontaneous activity test in mice and rats
Rotarod fatigue test
Grip strength test.
Gastric acid secretion, pH detection and bile secretion detection in rats
Gastrointestinal motility test in mice.
Renal function detection in rats.
•Integrated in-vivo and in-vitro cardiovascular safety pharmacology evaluation, fully compliant with ICH S7A/S7B regulatory requirements for global submission
•Full coverage of multiple species, one-stop completion of core and supplementary safety pharmacology studies to avoid multi-institution outsourcing risks
•Mature conscious telemetry platform for large animals with abundant historical baseline data to ensure high reliability of test results
•Full-process GLP quality control, supporting China-US dual submission with rich experience in regulatory inspection response
•Flexible solutions for different drug R&D stages, covering early compound screening and formal regulatory submission studies
•Stable and professional technical team with rich practical experience in safety pharmacology operation and problem handling
Integrated Safety Pharmacology and Toxicology Evaluation for Innovative Small Molecule Drugs
We provided full-process safety evaluation for a first-in-class anti-tumor small molecule drug, including cardiovascular and central nervous system safety pharmacology as well as subchronic toxicology studies. Customized study design was adopted based on drug characteristics to accurately predict safety risks. Full set of GLP-compliant data supported successful one-time IND approval without regulatory objections.
Safety Evaluation of Interventional Medical Devices
We conducted local toxicity, respiratory safety pharmacology and acute toxicology tests for a pulmonary interventional medical device. In strict accordance with medical device review standards, we efficiently completed studies and delivered compliant reports, helping clients obtain clinical trial approval rapidly.
Specialized Safety Pharmacology Evaluation for Inhaled Formulations
We carried out dual cardiovascular and respiratory safety pharmacology studies for an inhaled formulation. The test design simulated clinical inhalation administration scenarios with highly clinically relevant data, successfully supporting the client’s FDA IND submission.
