Moving client compounds swiftly into human studies
Frontage’s general toxicology group provides all of the resources you will need for your investigational plans. Our team of study directors, technicians, and program managers will help guide you through the non-regulatory tolerability, dose-range finding, and acute toxicology studies to help set you up for success in your regulated program.
Studies in general toxicology are conducted to see how toxic an article or compound is to animals. These studies are designed to determine the relationship between the various dosage levels administered and adverse effects, as well as to determine whether any potential target organs or functions may be affected.
Non-GLP Studies
The non-GLP studies leading into the GLP toxicology program are important elements of a successful program. Maximum Tolerated Dose (MTD) studies, repeat-dose range finding studies, exploratory PK studies, etc. are commonly needed to justify the selected dose levels for the pivotal studies to follow. A properly conducted preliminary package will lead to successful GLP studies by de-risking/removing less desirable compounds and allowing faster development of more appropriate lead candidates.
GLP Studies
Frontage GLP toxicology studies have supported hundreds of successful client IND submissions. All standard dosing regimens and species are supported, including primates, and our GLP toxicology studies are conducted in strict compliance with GLP and animal welfare regulations. Our quality assurance (QA) is managed on a global basis. Frontage’s “Two Continents – One System” approach ensures streamlined processes and common QA processes throughout the company – and with on-site QA teams embedded in each business unit.
Pivotal Toxicology
We offer pivotal toxicology studies for the safety and toxicity evaluation of candidate compounds. Our toxicological studies are conducted on a variety of animal models, ranging from IND-enabling to smaller toxicology studies, and provide a basis for identifying hazards and conducting safety assessments that support IND filing and support use in humans.
Our IND-enabling toxicology is performed by experienced scientists who can recommend appropriate study parameters and protocol elements, enabling the collection of a robust and comprehensive data package for IND submission. We offer comprehensive expertise to execute your IND study needs with services optimized to meet the most aggressive execution timelines.
General Toxicology
- Tolerability Studies
- Dose-Range Finding studies
- Acute to Subchronic to Chronic Toxicology Studies
- Acute Neurotoxicology Studies
| Drug Administration Routes | Major Laboratory Species Covered | Biopharmaceuticals |
|---|---|---|
| • Oral (gavage, diet, drinking water) • Ocular (topical, subconjunctival, intravitreal, peri-orbital) • Dermal • Intravenous (bolus injection, infusion) • Intramuscular • Subcutaneous • Other (intraperitoneal, intravaginal, sublingual, intranasal, etc.) | • Rodents • Rabbits • Mini-pigs • Canines • Primates | • Small molecule drugs • Biologics • Vaccines • Chemicals • Consumer products • Agrochemicals |
Related Services for Toxicology Programs
- ADME Services (Metabolism, QWBA, more)
- On-Site Bioanalytical
- On-Site Formulation Analysis
- Safety Pharmacology – Respiratory, Cardiovascular Telemetry, and CNS
- Stand-Alone or Embedded in Pivotal Toxicology Programs
- Infusion
- Program Management for Integrated Projects
Resources To Consider
Before GLP: The Value of Robust Exploratory Toxicology
6 Reasons To Do Exploratory Toxicology for Successful GLP Studies
Common Errors in IND-enabling Toxicology Programs
