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.
Consult our Safety Pharmacology Fact Sheet.
CORE SAFETY PHARMACOLOGY TESTS
|
SAFETY PHARMACOLOGY STUDY TYPE |
SPECIES |
|
Cardiovascular
|
Same as non-rodent* species in toxicology studies |
|
Central Nervous System
|
Generally, the same rodent species used in toxicology studies |
|
Respiratory
|
Same as non-rodent* species in toxicology studies |
*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.
THERAPEUTIC AREAS
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 comprehensive support research services and bioanalytical expertise.
Safety Pharmacology - FAQ's
What is the objective of the core battery of safety pharmacology tests?
According to Principles of Safety Pharmacology, published in the BJP, “for a drug to progress to patients, Safety Pharmacology must conclude that a drug has a sufficiently low potential to evoke adverse effects to be trialed in patients”. The safety pharmacology tests are therefore designed to analyze the effect of drugs on major organ systems in order to decide if advancement to human trials is advisable or possible.
Where can I find the ICH guidelines related to the core batter of safety pharmacology tests?
The information is accessible on the ICH website. Guideline S7A (SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS) and S7B (THE NON-CLINICAL EVALUATION OF THE POTENTIAL FOR DELAYED VENTRICULAR REPOLARIZATION (QT INTERVAL PROLONGATION) BY HUMAN PHARMACEUTICALS)
Are there different safety pharmacology considerations depending on molecule, i.e., large and small molecules?
The decision of whether to conduct safety pharmacology studies, and which studies to include, is influenced by a number of factors. We recommend speaking to one of our experts about the specifics of your molecule and development program to determine the best path forward.
Do all safety pharmacology studies follow the same design?
No, safety pharmacology studies are designed to define the dose-response relationship of any adverse effect observed. Different animal models and test systems are possible, depending on the specifics of your drug development program. The specific elements of a well-designed safety pharmacology program will include justification for species and study selection.