Our safety pharmacology team is characterized by a broad experience in the scientific and regulatory field. The expertise fully covers the Regulatory core battery of tests to assess potential side effects on the cardiovascular, central nervous system and respiratory system, using both in vitro and in vivo test systems, according to international guidelines such as ICH S7A and ICH S7B.
Our safety pharmacology team also supports early Discovery and Development studies, through in vitro liability testing as well as in vivo screens. The team also has very strong experience in investigative and problem solving studies; achieved by developing customised, fit-for-purpose designs, where possible taking advantage of a multi-disciplinary approach that combines different groups, such as pharmacology, toxicology, pathology and DMPK.
As recommended by a number of regulatory guidelines, including the recent ICH M3, we strive to integrate safety pharmacology endpoints to reduce the number of animals used and add robustness to the set of data generated. One very successful example of integration, that is quite unique to Aptuit, is the integrated assessment of neurobehavioural function with cardiovascular performance evaluation in the freely moving animal.
Our safety pharmacology services include:
In vitro safety pharmacology:
- Cardiac Safety Panel
- Manual patch-clamp (GLP/non GLP)
- In vitro /ex vivo seizure liability evaluation
- Liability and selectivity panel (CNS, CV, GI, hepatic, neuromuscular)
In vivo models:
- CV in vivo telemetry (mouse, rat, dog and NHP)
- Irwin/neurobehavioural FOB testing in rat, mouse and dog
- Respiratory function - WBP (rat)
- Rotarod/motor coordination and spontaneous locomotor activity
- Combined Neuro-Cardio dog model
- Seizure/Convulsion Liability Assessment (also as standalone services)
- Abuse Liability Assessment (also as standalone services)