Safety Pharmacology
Calvert’s preclinical pharmacologists are some of the most experienced and respected scientists in the CRO industry and are able to customize lead development strategies as well as replicate sponsor-derived methodologies.
Safety Pharmacology
This is an area Calvert has specialized in for the last 20 years. Calvert’s Safety Pharmacology program covers all aspects of the ICHS7A and S7B guidelines.
- First CRO to provide safety pharmacology services
- The first to provide GLP SP studies
- Effects on all major organ systems (CNS, CVS, Pulmonary, GI and Renal) examined
- Comprehensive series of tests designed to cover all Regulatory Guidelines
ICHS7A
We currently offer the following Core Battery tests:
1. Central Nervous System
- Neuropharmacological Profile (Rat or Mouse)
2. Cardiovascular System
- Anesthetized Hemodynamic Dog: Arterial blood pressure, Heart rate, LVP, +dp/dt, cardiac output, LVEDP and ECG
- CV Telemetry study in dogs or non-human primates
3. Respiratory System (Head Out)
- Pulmonary Function in rat or mouse airway resistance, tidal volume and minute volume, assessed in conscious animals
ICHS7B
1. Preliminary screening (NON-GLP)
- Anesthized QT dog/guinea pig/rabbit
- Purkinje fiber (subcontracted to ChanTest)
2. GLP Safety Pharmacology
- Anesthetized QT dog
- Anesthetized QT guinea pig
- Anesthetized QT rabbit
- Canine or rabbit purkinje fiber (subcontracted to ChanTest)
- Methoxamine QT prolongation and TdP in rabbits
- hERG (subcontracted to ChanTest)
3. Telemetry QT in dog and non-human primates
Other CNS Safety Tests
1. Central nervous neurotoxicity assay (rotarod)
2. Electroshock seizure assay
3. Barbiturate sleep time potentiation assay
4. Spontaneous motor activity assay
Other Organ Systems
1. Gastro Intestinal System
- Gastrointestinal propulsion in the mouse or rat (charcoal meal)
- Gastric emptying test in rats or mouse (glass beads, charcoal)
2. Renal System
- Urine volume and electrolyte excretion in the rat or dog
Discovery Pharmacology
- Leader in discovery pharmacology since 1969
- Over 150 standard pharmacology models
- Specialists in developing customized models
- Broad screening projects
- Covers all body functions/organ systems
- Specific mechanistic studies
Programs are in place in a wide range of therapeutic areas to identify/optimize leads or resolve specific mechanistic questions. Clients can select from well over one hundred standard pharmacology models, or work with us to develop a customized model. We are accustomed to tailoring cost-effective strategies to identify and characterize your molecules quickly and thoroughly.
Diabetes Discovery Program
Under the banner of Discovery Pharmacology we offer in vivo models to screen and/or develop lead compounds in the field of Diabetes. Our Diabetes Discovery Program has lead to the development of lead compounds that were ultimately licensed by several of our clients.
Lead Optimization
Calvert’s Pharmacology Group can fully characterize lead compounds using specific animal models tailored to your compound’s intended clinical indication. Programs are in place in the areas of Cardiovascular, CNS, Inflammation/Analgesia, Metabolic Diseases, and Cancer. Models are available in all standard laboratory species including non-human primate. Calvert has a reputation for innovation by developing novel models and techniques to accommodate specific sponsor requests. Our seasoned pharmacologists can answer tough development questions.
Lead Identification
Using limited amounts of test article, Calvert can help determine initial in vivo activity or select the best lead from a series. For example, over two hundred compounds were run through db/db mouse diabetes model to select lead compounds from an in-house discovery program, resulting in the identification and successful partnering of several compounds.
New Model Development
Non-human primate behavioral assessments, telemetry, and respiratory measurements in conscious animals are but a few of the new models recently developed.
Calvert can develop a novel model from published literature or from a specific client request. Cross specialty studies can be set up which draw upon many disciplines – i.e. classic pharmacology models with immunological or toxicokinetic components. New surgical models are constantly being developed. For example, we routinely utilize pre-cannulated animals for pharmacological evaluations of test articles.




