Safety Pharmacology Testing
Respiratory system safety pharmacology studies are essencial for evaluating the potential effects of new compounds on pulmonary function and respiratory control. These studies form part of the core battery recommended by ICH guidelines (M3, S7A and S6) and are required prior to first-in-human trials to identify possible adverse effects such as respiratory depression, airway obstruction, or altered respiratory patterns.
Preclinical regulatory CRO
Established – 2000
At Vivotecnia, we perform respiratory system evaluations using non-invasive and sensitive methods in conscious, unrestrained animals. Our studies follow international guidelines and provide reliable data to support regulatory submissions and mitigate early development risks.
We use plethysmography systems to monitor respiratory parameters such as tidal volume, respiratory rate, minute ventilation, and apneic episodes in conscious animals. Our methodology allows for real-time data acquisition under physiological conditions and can detect subtle changes in respiratory function induced by test substances. Researchers usually conduct these studies in rodents using whole-body plethysmography and can adapt them to non-rodent models as required. Our team ensures alignment with GLP standards and ICH guidelines, offering flexible study designs based on the compound’s pharmacological profile.
Advanced Therapies Medicial Products (ATMPs)
Inhaled Products & Vaccines
Our respiratory studies are conducted using state-of-the-artplethysmography chambers for rodents, fully integrated with digital acquisition systems. The chambers are non-invasive, stress-minimizing, and allow for real-time monitoring without anesthesia or restraint.We execute all studies in GLP-certified environments with full data traceability and QA oversight.
We use whole-body and nose only plethysmography systems that provide accurate and reproducible respiratory data.
We train our technicians and scientists in respiratory safety pharmacology and regulatory study design.
Our studies comply with ICH S7A and ICH S7B, OECD and EMA guidelines, ensuring your data is fit for global submissions.
Respiratory assessments can be integrated into general toxicology or safety pharmacology packages.
Ensure respiratory safety before clinical
trials! Contact our team to design a
compliant and reliable respiratory safety
pharmacology study
