Safety pharmacology studies are required to assess the impact of your new chemical entity or biotechnology-derived product for human use on vital organ systems before first-in-human drug testing.
Altasciences’ preclinical services, which include solutions in multiple species, can support these essential studies. Safety pharmacology plays a critical role by providing valuable insight into potential adverse effects of drug candidates. The data collected is used to guide physicians in the safe conduct of clinical trials through design and execution.
A core battery of safety pharmacology tests are required by international regulatory guidelines (ICH S7A/S7B) prior to initiation of the first human dose of an investigational medicine. This core battery of tests includes cardiovascular function, respiratory function, and central nervous system behavior.
- Cardiovascular function – non-human primate, dog
- Respiratory function – non-human primate, dog
- Central nervous system behavior (Irwin, FOB) – rat, mouse
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.