 BRM
performs a wide range of non-clinical laboratory studies
that support new drug applications (NDAs) for permits
regulated by the Food and Drug Administration (FDA).
The primary goal of toxicology studies
is to determine the effect of compounds on biological
systems. These
studies generally fall under the scope of Good Laboratory
Practices (GLP) Regulations.
BRM can custom design short or long term toxicity studies
to evaluate potential negative effects of a client’s
compound. Throughout the study, animals are monitored
daily by trained staff and weekly by a veterinarian.
Upon termination of a study, animals are fully necropsied
and analyzed for gross pathological changes in the presence
of a veterinarian.
Specific organs can be taken and processed in a variety
of manners to evaluate toxic effects.
GLP compliant toxicology
studies at BRM include:
- Acute Single Dose: Primary
Assessment
- Sub-Acute Toxicology: Dose Ranging for
Sub-Chronic Toxicology
- Sub-Chronic Toxicology: To Evaluate
Short-term Pharmacological Effects (<6 months)
- Chronic
Multidose (>6months)
- Dermal Toxicology
- Chronic Toxicology Studies:
To Evaluate Carcinogenicity and Reproductive Toxicology
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BRM
is also capable of performing the above and other studies
outside the scope of GLP-regulations (non-GLP) including:
- Basic Discovery
Research to Develop New Methodologies
- Efficacy Studies
- Preliminary Toxicology
- Safety Studies:
To Evaluate Potential Adverse Reactivity
- Immunogenicity:
To Evaluate Immune Response to Agent
Learn more about:
Efficacy
Toxicology
Pharmacokinetics (PK)
Contact
us for custom research design.
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