Your preclinical development partner
Program development and implementation
With over 25 years of proven experience in vaccine and drug development, Noble’s scientists can manage your drug development programs through each phase of the preclinical process, from design and implementation to regulatory support of your IND, IDE or PMA FDA submission.
With our state-of-the-art, FDA-inspected GLP facilities, an extensive set of standard operating procedures, and an experienced team, Noble can help you get from concept to the clinic faster and more efficiently.
We can guide you through your preclinical testing or turn the entire project over to us and we will handle all aspects from protocol to final report.
- FDA-inspected GLP facility
- Standard operating procedures that cover all aspects of animal care, animal procedures, equipment and facility operations
Operate in accordance with
Fully accredited by
Our studies are designed and run by seasoned experts.
- Pharmacokinetic & pharmacodynamic drug testing
- Pharmacodynamic modeling for candidate selection, safety evaluation and patient dosing strategies
We can also:
- Identify appropriate dosing routes
- Conduct dose range finding studies
- Perform studies to establish the maximum tolerated dose
We have a large collection of reference compounds for comparator studies.
If you need assistance with drug candidate pre-formulation and formulation development, Noble scientists will apply their expertise to address your needs.
Noble scientists will work with you to examine the toxicology of your drug candidate as part of your development program.
Studies types include:
- Acute, subchronic, & chronic toxicology
- Repeat dose
GLP Toxicology Services
Toxicology studies are required to determine the adverse effects of drug candidates and the effect of dosage on toxicity. To assess toxicity, Noble offers a wide range of GLP and non-GLP toxicology services.
- Exploratory Toxicology
- General Toxicology
- Immunotoxicology and Immunogenicity
- Development and Reproductive Toxicology
In addition to GLP toxicology services, Noble Life Sciences provides all aspects of the GLP process from design to regulatory support of your IND, IDE or PMA FDA submission.
- Dose range finding
- Single and repeat dose
- Acute, subchronic and chronic
- Local tolerance
- Ocular and skin irritation
- Irritation evaluations
- Median Lethal Dose (LD50)
- Maximum Tolerated Dose (MTD)
- No Observable Effect Level (NOEL)/No
Observable Adverse Effect Level (NOAEL)
Routes of Administration
We offer a variety of drug administration options including:
- Continuous infusion
- Dietary admixture
- Oral gavage
We offer a variety of species options including:
- Rats, Cotton Rats
- Guinea pigs
- Domestic swine
- Mini pigs
Vaccine Development Services:
- Single-dose acute and repeat-dose studies
- Biodistribution studies
- Clinical observations; complete clinical chemistry and pathology package
Scientists with over 15 years of GLP experience
Quality assurance professionals with over 25 years of experience in the industry, including board-certified veterinarians, PhD and Master level scientists, as well as AALAS-certified technicians and technologists.
Stephen K. Horrigan, Ph.D.
Chief Scientific Officer
We are proud of our ability to successfully customize studies and develop unique procedures to facilitate the research and development of your product.
Resources & White Papers
PASSIONATE ABOUT COLLABORATING FOR A CURE
The mouse and ferret animal models are the most widely used models for influenza studies. Each has its advantages. The...
Immunophenotyping of Tumor-Infiltrating Immune Cells in Mouse Syngeneic Tumor Models Using Multi-Color Flow Cytometry Assays
The in vivo animal tumor models possessing fully functional immunity are essential for preclinical...
Figure 1. Overview of the biodistribution study of cell/gene therapy (CGT) product. The CGT product is injected into mice; tissue samples are harvested and DNA is isolated from...