Toxicology

Naïve, protein-naïve and non-naïve study subjects.

Dose formulation for liquid forms with sample retention for analysis.

Investigational and organ-specific toxicity evaluations (cardiac, hepatic, renal and respiratory)

Neurotoxicity and immunotoxicity assessments

Organ-specific or complete histology and pathology evaluation.

Pre-formulated liquid or solid dosage forms.

Acute, short-infusion or repeated dosing (maximum tolerated dose, dose range finder, repeat dose range finder) study designs.

Full clinical chemistry, clinical pathology and clinical toxicology support.

Tissue-specific safety biomarker levels by biosampling, biopsy or microdialysis.

Information
Assess the early toxicology of test compounds

Protocol
The test compound is administered acutely orally (intragastric; one dose or multiple dose levels) or intravenously (one dose level) at different time or in different sets of primates (one gender). The adverse effects are evaluated during the course of 24 to 72 hours by clinical evaluation, clinical pathology and/or clinical toxicology.

Delivery
Clinical evaluation, clinical pathology and toxicology.

Information
Assess the acute toxicology of test compound or protein and identify the doses for repeat toxicology

Protocol
The test compound is administered acutely by the intended clinical route (multiple dose levels) and/or intravenously (one dose level) in different sets of primates (both gender). The test protein is administered by the intentend clinical route. The vehicle is used as a reference control. The adverse effects are evaluated during the course of the study by clinical evaluation, clinical pathology and clinical toxicology. Systemic and organ-specific toxicity are evaluated by gross pathology and histology.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for drug level analysis. Alternatively, bioanalysis is conducted. Clinical evaluations, clinical pathology and toxicology. Gross pathology and histology. Full report.

Information
Assess the toxicology profile of the test compound or protein

Protocol
The test compound is administered repeatedly using the intended clinical route in different sets of primates (both gender). The vehicle is used as a reference control. Toxicokinetic evaluation is conducted on the first and last day of dose administration. The adverse effects are evaluated during the course of the study by clinical evaluations, clinical pathology and clinical toxicology. Systemic and organ-specific toxicity are evaluated by gross pathology and histology. A recovery phase can be added.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for drug level analysis. Alternatively, bioanalysis is conducted. Clinical evaluations, clinical pathology and toxicology. Gross pathology and histology. Full report.

Information
Assess the mechanistic toxicopharmacology of the test compound or protein

Protocol
The test compound or test protein are administered by a route different than the clinical intented route. The mechanistic safety evaluation is combined with genetic, physiological and pharmacological assessments. The adverse effects are evaluated during the course of the study by clinical evaluation, clinical pathology and clinical toxicology. Systemic and organ-specific toxicity are evaluated by gross pathology and histology.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for drug level analysis. Alternatively, bioanalysis is conducted. Safety assessments, clinical evaluations, clinical pathology and toxicology. Gross pathology and histology. Full report.

Information
Assess the organ-specific toxicology of the test compound or protein

Protocol
The test compound or test protein are administered using the intended clinical route or using a direct supply route (e.g. cerebrospinal, intra-ocular, etc…). The organ specific effects are evaluated using safety markers (behavioral, physiological, genetic, protein-based). Typical markers are targetting the cardio-vascular, neurological, endocrine, muscular, renal and respiratory systems. The adverse effects are evaluated during the course of the study by clinical evaluations, clinical pathology and clinical toxicology. Systemic and organ-specific toxicity are evaluated by gross pathology and histology. A recovery phase can be added.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for drug level analysis. Alternatively, bioanalysis is conducted. Biomarkers, safety assessments, clinical evaluations, clinical pathology and toxicology. Gross pathology and histology. Full report.

Information
Assess the effect of the test compound or test protein on the immune system.

Protocol
The test compound or test protein are administered using the intended clinical route. The immune specific effects are evaluated using protein or cell-based immune biomarkers and immunophenotyping. The adverse effects are evaluated during the course of the study by clinical evaluations, clinical pathology and clinical toxicology. Systemic and organ-specific toxicity are evaluated by gross pathology and histology. A recovery phase can be added.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for drug level analysis. Alternatively, bioanalysis is conducted. Immunotoxicology assessments, clinical evaluations, clinical pathology and toxicology. Gross pathology and histology. Full report.

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