Human Health | Test and Evaluation
Preclinical IND-Enabling Toxicology Services
Whether you need routine analysis or novel solutions, MRIGlobal’s toxicology experts deliver.
As a contract research organization (CRO), our team offers a wide variety of toxicology and PK studies in various small and large animal species for preclinical drug development, veterinary product submissions, and industrial chemicals registration. We specialize in a wide variety of routes of administration including oral, inhalation, intravenous, intraperitoneal, subcutaneous, intramuscular, intranasal, and dermal. In addition, we provide in-house bioanalytical and dose formulation analysis services.
Capabilities
MRIGlobal has the experience and in-depth knowledge to conduct a wide variety of studies and project work. Our preclinical IND-enabling toxicology services include:
Through escalating or de-escalating dose levels, MRIGlobal will determine the maximum tolerated or maximum feasible dose of a target drug or biologic.
- Characterize the toxicity and toxicokinetic profile of a target drug or biologic via any route of exposure and frequency
- Bioanalysis and TK analysis
- Determination of desired dose for pivotal GLP studies
Evaluation of toxicity via:
- In-life parameters including, but not limited to, clinical observations, body weight, food consumption, ophthalmology, ECG/EKG, etc.
- Clinical Pathology (clinical chemistry and hematology parameters)
- Histopathology Services
- TK Profile with WinNonLin analysis/results
- Mice/Rats
- Guinea pigs
- Rabbits
- Cats/Dogs
- Minipigs/Pigs
- Non-human primates
- Oral (gavage, diet, and capsule)
- Implant
- Inhalation and aerosol delivery
- Parenteral
- Intravenous, subcutaneous, intradermal, intramuscular, and intraperitoneal
- Intranasal
- Intrathecal
- Topical/Dermal
- Ocular
- Intravaginal and intrapenile
- Rectal
- Others available upon request
- Method development and validation
- Impurities isolation and identification
- Materials characterization and release
- Short-term and long-term stability assessment
MRIGlobal has bioanalytical capabilities to perform test article concentration analysis of blood samples. PK analysis is conducted using WinNonLin software. PK parameters include Cmax, Tmax, T1/2, AUC, etc.
Ask us how we can customize and develop a specific animal model for your test article application.
Our Staff
Our technical staff includes experienced toxicologists (DABT/Ph.D.); clinical veterinarians (DVM, board-certified surgeon); registered veterinary technicians (RVT); and AALAS accredited animal care personnel (ALAT, LAT, LATG).
Work with us
MRIGlobal looks forward to contributing our expertise where it matters most.
See how MRIGlobal can enable your project to take the next step with our Preclinical IND-Enabling Toxicology Services.