Respiratory Safety Assessment Laboratory
JOINN has established the largest inhalation laboratory in China, with the capability and experience to conduct non-clinical evaluations of various clinical dosage forms of inhaled drugs. It has completed numerous non-clinical evaluations for inhaled new drugs for domestic and international clients. Relying on the comprehensive service platform of JOINN, evaluations can be conducted for drugs, chemicals, and pesticides. It can provide high-quality and efficient services for clients, including evaluation of aerosol generation characteristics of test substances, inhalation toxicology studies, lung tissue distribution studies of inhaled preparations, pulmonary mucosal irritation studies, local and systemic pharmacokinetic studies of inhaled agents, as well as distinctive drug efficacy evaluations.
Service
Pharmacodynamic research
Toxicological research
Assessment of NOAEL in the lungs (pathological examination, functional examination)
Pulmonary function evaluation (ventilatory function, blood gas analysis)
Pharmacokinetic and toxicokinetic studies (bioavailability detection)
Animal Species
Rodents (mice, rats)
Non-rodents (dogs, non-human primates)
Animal Models
Pulmonary fibrosis
Asthma
Lung injury
Pneumonia
Chronic obstructive pulmonary disease (COPD)
Pulmonary arterial hypertension
Administration Routes
Whole-body exposure inhalation (rodents)
Oral and nasal inhalation (rodents, dogs, non-human primates)
Intratracheal nebulization (inhalation solution, dry powder)
Evaluable Types
Inhalation solutions (IS)
Metered dose inhalers (MDI)
Dry powder inhalers (DPI)
Service Advantages
Rich experience in non-clinical evaluation, with over 30 Class I/II new drug projects completed
Completed the first non-clinical evaluation of a Class I inhaled drug in China, which successfully entered clinical trials
Completed the first non-clinical evaluation of a Class I inhaled biological drug in China, which successfully entered clinical trials
Completed the world's first non-clinical evaluation of an inhaled vaccine, which successfully entered the market
Experience in dual reporting in China and the United States for inhaled new drugs, with mature service experience for foreign clients
Fully compliant with OECD technical requirements
High quality and strict standards to facilitate clinical translation
The largest experimental throughput in China, with strong service capabilities
