Safety pharmacology and Toxicology

All our toxicology services and pharmaco-safety are designed to provide the best expertise.
Our teams can help you customize the strategy of development of your products and advise you to identify the best design
• Characterize side effects
• Identify potential toxicity on target organs
• Identify doses
In general, to achieve toxicological studies 2 species are required, one of them is rodent animals such as mice and rats and the other specie must be non-rodent. SPM Biocameltec allows you to complete your toxicological studies and propose several species such as dogs and rabbits and other non-rodent species.
Acute Toxicity
To evaluate, the Median Lethal Dose (LD50) after a single dose administered through one or more routes, one of which is the intended route of administration in humans, The Maximum Tolerated Dose (MTD) and No Observable Effect Level (NOEL), The identification of potential target organs for toxicity, the determination of reversibility of toxicity, the identification of parameters for clinical monitoring and the selection of doses for repeated-dose toxicity tests

• Duration: A few days to 2 weeks after a single dose.
• Animals: Rabbits or dogs. Other species are also feasible upon request.
• Dose and route of administration: Single administration by oral (by gavage or with food) or other route of administration such as subcutaneous, intraperitoneal, intravenous, topical (epicutaneous), inhalation and intranasal.
• Parameters: Weight change, clinical pathology, signs of toxicity, gross necropsy and mortality.

Subacute Toxicity (Repeated Dose)
 To determine toxicity after repeated administration of the test material and to help establish doses for subchronic studies.

• Duration: 2 weeks (à verifier).
• Animas: Rabbits, Dogs or other species (upon request of the customer).
• Dose and route of administration: 3 to 4 doses given by the same routes as previous toxicity tests.
• Parameters: Weight change, signs of toxicity, pathology and histopathology, clinical pathology and mortality.

Subchronic and Chronic Exposure
For the identification of NOEL, the characterization of dose-response relationships following repeated doses, the identification and characterization of specific organs affected after repeated administration and the prediction of  a reasonable and appropriate dose for chronic exposure studies (maximum tolerated dose or MTD)

• Duration: Commonly 90 days, but varies depending the animal species used in the protocol (can be prolonged to 6 months or up to 10% of species’ lifespan).
• Animals: Rabbits, dogs. Other species can be used upon request.
• Dose and route of administration: At least 3 doses given by the same routes as previous toxicity tests; the lowest producing no apparent toxicity and the highest producing toxicity but less than or equal to 10% mortality.
• Parameters: Weight change, signs of toxicity, pathology and histopathology, clinical pathology and mortality.

Chronic Exposure
To evaluate the cumulative toxicity of chemicals and to assess carcinogenic potential.

• Duration: For non-rodents species including dogs, 12 months or longer (or up to 10% of species’ lifespan). Length depends on intended period of human exposure.
• Animal: Rabbit, dogs and other species (upon request).
• Dose Administration: According to subacute and subchronic toxicity studies.
• Parameters: Weight change, signs of toxicity, pathology and histopathology, clinical pathology and mortality.

Safety Pharmacology
To evaluate the effects of drugs or biomateri­als on the function of vital organ systems, (cardiovascular, respiratory and central ner­vous systems). These studies define expected and unexpected pharmacological effects of the test material, especially on parameters associated with desired clinical activity.

• Duration: Variable depending on the test system.
• Animals: Selected pharmacologically relevant species; more than one species indicated for cases with no previous data or when species relevance is difficult to determine.
• Dose Administration: Variable, depending on the expected effective dose range and test system.
• Parameters: Respiratory (lungs and bronchi), Gastrointestinal and hepatic (esophagus, stomach, intestines, liver), Renal (kidney), Cardiovascular (heart and blood vessels), Blood, Endocrine (thyroid and other endocrine glands and nervous/neurobehavioral (CNS and behavior)