Here, you will find information that allows you to learn more about the company from which you are getting your research done. BTS is a Contract Research Organization that delivers GLP and Non-GLP biological services to clients in pharmaceutical/biopharmaceutical, biotech, academic research, medical device and related industries.

Since 2001, BTS Research has executed toxicology studies for numerous small and large organizations, from . Thanks to our experience in dealing with a variety of organizations, small or large virtual to fortune 50, we provide customer focused research that is sensitive to your timelines to help you reach your research goals without added cost or compromised quality.

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Acute Toxicity

Acute toxicity describes the adverse effects of a substance which result either from a single exposure or from multiple exposures in a short period of time (usually less than 24 hours). To be described as acute toxicity, the adverse effects should occur within 14 days of the administration of the substance.

Evaluation of acute toxicity data should include the relationship between the exposure of animals to the test substance and the incidence and severity of all abnormalities, including behavioral and clinical abnormalities, the reversibility of observed abnormalities, gross lesions, body weight changes, effects on mortality, and any other toxic effects.

BTS Research has a core competency in performing these studies following standard or custom protocols and established SOP’s. The study can be conducted under GLP per customer request.

Subchronic Toxicity

Subchronic toxicity studies in rodents and large animals (dogs, NHPs) are repeat dose studies that are generally conducted for 28 to 90 days and can be conducted for up to 12 months. Results of these studies (1) can help predict appropriate doses of the test substance for future chronic toxicity studies, (2) can be used to determine NOAELs (No Observable Adverse Effect Level) for some toxicology endpoints, and (3) allow future long-term toxicity studies in rodents and non-rodents to be designed with special emphasis on identified target organs.

BTS Research has a core competency in performing these studies following established SOP’s. The study can be conducted under GLP per customer request.

Neurotoxicity 

Behavioral studies are conducted to evaluate the potential of a substance to be a neurotoxin which alters the normal activity of the nervous system. This can eventually disrupt or even kill neurons, key cells that transmit and process signals in the brain and other parts of the nervous system. Symptoms may appear immediately after exposure or be delayed. They may include limb weakness or numbness, loss of memory, vision, and/or intellect, headache, cognitive and behavioral problems and sexual dysfunction. BTS Research has a core competency in performing these studies following established SOP’s. The study can be conducted under GLP per customer request.

Chronic Toxicity

Chronic toxicity studies provide a thorough examination of the dose effect of a given substance on homeostasis, bodily function, induced diseases, and the effect on lifespan. Chronic toxicity studies provide the bulk of the preclinical information used for assessing safety and risk. The study is conducted in multiple species, in both sexes, and for a duration that approaches the lifespan of the animal. These are very large and complex studies that necessitate a great deal of day-to-day management. There are multiple intermediate clinical evaluations, including daily observations, weekly food and water consumption, and body weight determinations. At the termination of the study, or at times of interim sacrifices, all animals are necropsied under supervision of a board certified pathologist.

BTS Research has a core competency in performing these studies following established SOP’s. These studies are conducted under GLP.

Range Finding Studies

Range-finding studies are usually conducted to provide preliminary identification of the target organs of toxicity as well as to select doses for the definitive study intended to support the clinical trials. Range-finding studies are usually 7, 10 or 14 days long. BTS Research has a core competency in performing these studies following established SOP’s and adhering to FDA GLP requirements.

Maximum Tolerated Dose

The maximum tolerated dose (MTD) is the highest daily dose of a substance that does not cause overt toxicity in rodents or large animals. This dose is then used for a longer-term safety assessment in the same species, usually lasting two years or a lifetime. The rationale for using the MTD is to maximize the likelihood of detecting any chronic disease effects of a substance, including cancer. Using higher doses also increases the statistical likelihood of detecting the intrinsic hazards of substances.

BTS Research has a core competency in performing these studies following established SOP’s. The study can be conducted under GLP per customer request.

Safety Pharmacology

The purpose of the safety pharmacology core battery is to investigate the effects of the test substance on vital functions. In this regard, the cardiovascular, respiratory, and central nervous systems are usually considered the vital organ systems that should be studied in the core battery.

Central Nervous System
Effects of the test substance on the central nervous system should be assessed appropriately. Motor activity, behavioral changes, coordination, sensory/motor reflex responses and body temperature should be evaluated. For example, a functional observation battery (FOB), modified Irwin’s, or other appropriate test can be used.

Cardiovascular System
Effects of the test substance on the cardiovascular system should be assessed appropriately. Blood pressure, heart rate, and the electrocardiogram should be evaluated. In vivo including methods for repolarization and conductance abnormalities should also be considered. Effects of the test substance on the cardiovascular system should be assessed appropriately. BTS Research utilizes the DSI equipment and the Ponema software platform for both jacketed and implantable sensors.

Respiratory System
Effects of the test substance on the respiratory system should be assessed appropriately. Respiratory rate and other measures of respiratory function (e.g., tidal volume or hemoglobin oxygen saturation) should be evaluated. Clinical observation of animals is generally not adequate to assess respiratory function, and thus these parameters should be quantified by using appropriate methodologies. BTS Research has a core competency in performing safety pharmacology studies following established SOP’s and ICH standards.

BTS Research has a core competency in performing safety pharmacology studies following established SOP’s and ICH standards.