Nonclinical safety assessment is a critical technical gateway linking drug and medical device R&D to clinical application. Safety pharmacology focuses on predicting risks to vital physiological systems, while toxicology studies comprehensively characterize potential hazards of test articles. Together, they provide scientific, regulatory-compliant and traceable data to support clinical trial design and global registration. JOINN Laboratories has long specialized in nonclinical safety assessment, building a standardized platform covering all test article types and full R&D cycles. Guided by scientific rigor and regulatory compliance, we deliver end-to-end safety assessment solutions aligned with international standards, strict quality control and customized study designs.
We hold a leading industry position in toxicology evaluation, especially for novel drugs with first-in-class targets, new mechanisms and innovative formulations. Our unparalleled expertise stems from three core strengths: in-depth mastery of global regulatory guidelines and review pathways (FDA, EMA, NMPA); industry-leading volume of novel drug toxicology projects with extensive real-world data and complex case experience; and continuous investment in cutting-edge technologies to optimize models and methods, resolving unique safety assessment challenges for innovative products. We also offer specialized safety assessment for medical devices, aligning with device-specific regulatory standards to deliver integrated drug-device solutions.
Safety pharmacology is a critical preclinical step to identify potential adverse reactions in vital physiological systems, focusing on cardiovascular, central nervous system (CNS) and respiratory safety. Conducted in strict compliance with ICH S7A and ICH S7B guidelines, these studies mitigate clinical trial risks and are mandatory for IND submissions. Our GLP-compliant safety pharmacology studies leverage state-of-the-art equipment and expert scientific teams to deliver accurate, traceable data that fully meets global regulatory submission requirements.
This service evaluates effects of test articles on cardiovascular function, measuring key indicators including heart rate, blood pressure, ECG and myocardial contractility to identify risks of arrhythmia and hemodynamic abnormalities. Advanced technologies like conscious animal telemetry and patch-clamp ensure high accuracy and clinical relevance, especially for cardiotoxicity-high risk compounds.
Services: Conscious cardiovascular telemetry, hERG channel inhibition assay, isolated heart perfusion, blood pressure/heart rate monitoring, ECG analysis
Key Advantages: Automated unbiased data capture; full ICH S7B compliance; compatible with drug and medical device extract testing
Standardized behavioral and neurological testing identifies potential CNS effects including sedation, convulsions, motor dysfunction and cognitive impairment, providing critical data for safe clinical dosing. Study designs align with global regulatory expectations for high reliability.
Services: Open field test, rotarod assay, convulsion threshold testing, neurobehavioral scoring, cognitive function assessment
Key Advantages: Standardized reproducible protocols; expert behavioral assessment; customizable neurotoxicity evaluation
Testing evaluates risks of abnormal respiratory rate, tidal volume and oxygen saturation, focusing on inhaled drugs, respiratory-targeted compounds and pulmonary interventional devices. Studies mimic clinical exposure conditions to fully assess respiratory function impairment.
Services: Respiratory rate/tidal volume monitoring, oxygen saturation testing, airway resistance assessment, pulmonary ventilation test
Key Advantages: High-precision respiratory monitoring; clinical-mimic exposure; tailored for inhaled drugs and pulmonary devices
Toxicology serves as the cornerstone of nonclinical safety assessment, systematically characterizing toxicity profiles, target organ damage, dose-response relationships and safe dose ranges via in vitro and in vivo studies. It acts as a critical gatekeeper for clinical trial entry. JOINN operates a fully GLP-compliant toxicology platform, delivering globally accepted regulatory reports. Our unmatched experience in novel drug toxicology solidifies our industry-leading position.
Foundational toxicology assessments evaluate acute, subchronic and chronic toxicity via single and repeated-dose exposure, identifying target organs and safe dose ranges to guide clinical dosing. Full species and administration route coverage supports drug and medical device extract testing.
Services: Acute toxicity, subchronic toxicity, chronic toxicity, dose range finding (DRF)
Key Advantages: Decades of historical control data; full species coverage; GLP-compliant globally accepted data
Mandatory for innovative drugs and long-term implantable devices, these studies assess risks to fertility, embryonic/fetal development, offspring health and genetic integrity, conducted in strict alignment with ICH S5 guidelines to mitigate reproductive and genetic hazards.
Services: Fertility & early embryonic development, embryo-fetal development, perinatal development, genotoxicity testing
Key Advantages: Extensive novel drug reproductive toxicology experience; high regulatory approval rate; tailored for medical device testing
Targeted testing addresses gaps in standard toxicology for specialized formulations, topical products and medical devices, focusing on local irritation, sensitization, hemocompatibility and immunotoxicity, fully aligned with ISO 10993 biocompatibility standards.
Services: Local irritation, sensitization, hemolysis, immunotoxicity testing
Key Advantages: ISO 10993 device-aligned protocols; high-sensitivity testing; customized medical device safety solutions
Safety pharmacology, GLP toxicology and integrated nonclinical safety assessment
A: Core assessments cover cardiovascular, central nervous system and respiratory safety. Additional specialized testing is available for unique products, all aligned with ICH S7A/S7B and global regulatory requirements.
A: All regulatory toxicology studies follow GLP principles and comply with ICH, FDA, EMA and NMPA guidelines. Medical device testing additionally aligns with ISO 10993 standards.
A: We lead the industry in novel drug toxicology project volume, with deep regulatory expertise and extensive complex case experience. Our customized study designs ensure high regulatory compliance and approval rates.
A: Yes. We provide specialized safety pharmacology, toxicology and biocompatibility testing for medical devices, aligned with device-specific regulatory pathways.
A: Yes. All reports are GLP-compliant, fully documented and traceable, meeting IND submission requirements of NMPA, FDA, EMA and other global regulators.
A: It is important to study potential adverse pharmacological activities using appropriate animal models, and detailed monitoring of these activities should be conducted in conjunction with toxicology studies and/or clinical trials when necessary. Safety pharmacology studies are used to detect functional indicators of potential toxicity, which can be evaluated either through separate studies or integrated into toxicology studies. The purpose of safety pharmacology studies is to reveal any effects on the function of major physiological systems (such as the cardiovascular, respiratory, renal, and central nervous systems). These studies may also include test systems using isolated organs or other non-integral animal models. All the aforementioned studies can be used to explain the mechanism of organ-specific toxicity, and the relationship between toxicity and human application as well as indications should be carefully considered.
A: (1) Clarify the unintended pharmacodynamic properties of the test article that may be related to human safety; (2) Evaluate the adverse pharmacodynamic and/or pathophysiological effects of the test article observed in toxicology studies and/or clinical trials; (3) Investigate the mechanism of observed and suspected adverse pharmacodynamic effects. A research plan that meets the above research objectives should be clearly elaborated.
A: Ensuring the quality and reliability of non-clinical safety studies is crucial. Under normal circumstances, the quality and reliability of studies should be guaranteed by following Good Laboratory Practice (GLP) regulations when conducting the studies. Due to the unique design and practical operability of certain safety pharmacology studies, the implementation of the studies may not be able to comply with GLP regulations. Even if full compliance with GLP regulations is not achieved, it must be emphasized that the quality and completeness of safety pharmacology study data should be ensured. When a study is not conducted in accordance with GLP, the repeatability of the study process should be guaranteed through appropriate documentation of study implementation and archiving of data. Any study or part of a study that does not comply with GLP should be properly justified, and the potential impact on safety pharmacology indicators should be explained. Core battery safety pharmacology studies should generally comply with GLP regulations, and every effort should be made to conduct follow-up and supplementary studies in accordance with GLP regulations. Safety pharmacology studies can be part of general toxicology studies, in which case they should be conducted in compliance with GLP regulations. Primary pharmacodynamics studies do not need to comply with GLP regulations. In general, secondary pharmacodynamics studies do not need to comply with GLP. During the compound screening process, results from secondary pharmacodynamics studies can contribute to safety pharmacology evaluation. When there are no safety concerns (e.g., no positive results in safety pharmacology indicators, or no safety concerns from the perspective of chemical classification or therapeutic classification), these studies do not need to be repeated in accordance with GLP regulations. In certain cases, when the results of secondary pharmacodynamics studies may be of significant value for evaluating potential adverse reactions in humans, these studies should be conducted in compliance with GLP regulations.
