Safety pharmacology
Safety pharmacology
Having an understanding of your drug’s impact on vital organ systems helps in the planning of human trials. Our safety pharmacology services can help you transition smoothly from preclinical to clinical pharmacology. Our experts conduct safety pharmacology studies according to ICH safety pharmacology guidance S7A and S7B, ensuring your data meets all regulatory standards.
THE GOAL OF SAFETY PHARMACOLOGY STUDIES
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. In some instances, based on scientific rationale, the core battery of safety pharmacology testing should be supplemented. Our subject matter experts are happy to guide you in determining which in vivo safety pharmacology studies are recommended for your development program.
CORE SAFETY PHARMACOLOGY TESTS
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SAFETY PHARMACOLOGY STUDY TYPE
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SPECIES
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Cardiovascular
- Blood pressure, heart rate, and electrocardiogram;
- Methods for repolarization and conductance abnormalities should also be considered.
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Same as non-rodent* species in toxicology studies.
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Central Nervous System
- Motor activity, behavioral changes, coordination, sensory/motor reflex responses and body temperature
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Generally, the same rodent species used in toxicology studies.
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Respiratory
- Respiratory rate and other measures of respiratory function (e.g., tidal volume or hemoglobin oxyge saturation)
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Same as non-rodent* species in toxicology studies.
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*Combination of the cardiovascular and respiratory safety pharmacology assessments in the selected non-rodent species is also a suitable approach, using surgically implanted animals. This combination permits study of time-dependent effects, and insight into possible mechanisms of action. Since two of the three core safety pharmacology assessments are combined, this approach can decrease the number of animals used (3Rs), and reduce cost and other resources.
