Our laboratories perform general toxicology safety evaluation studies for the pharmaceutical and biotechnology industries. We have experienced toxicologists who design and implement safety programs for regulatory submission.
Routes of administration:
- Guinea pig
- Non-human primate
Single Dose through lifetime administration studies including acute, subacute, sub-chronic, chronic and carcinogenicty.
- Dose formulation analysis
- Bioanalysis of biological samples
- Data review and analysis
- Report preparation
In Vitro Toxicology
- Cardiac Toxicity Screen including hERG
- Ocular Toxicity Screen
- Dermal Toxicity Screen
- Drug-Drug Interactions
- Endocrine Screens
Safety pharmacology covers the five major organ systems (CNS, Cardiovascular, GI, renal, pulmonary), and extends to in vitro assays. For each organ system there is a series of tests offered, all in compliance with GLP standards. Telemetry is availability in two different species. Irwin profiling for CNS effects is conducted on all species including mouse, rat, dog, and primate. Colonies can be made available for repetitive dosing designs, providing clients with cost-effective solutions for multiple lead evaluations. Packages of safety pharmacology tests range from the standard Tier I (evaluation of five major organ systems in single tests to satisfy basic regulatory requirements) to the full MHW Category A list.
- Single dose PK and bioavailability
- Multiple dose studies
- Mass balance and tissue distribution using a variety of radio-labeled compounds
Global BDI laboratories are experienced in assessing:
- The evaluation of test article for immunotoxicity
- The measurement of the influence of immunogenicity of the test article on toxicology and toxicokinetic outcomes
- The evaluation of immune activation via complement pathways or allergic reaction
Species include rat, rabbit and monkey. Segments I, II and III by all routes.