General & Specialized Toxicology
Safety data your program can actually make decisions on.
For more than 80 years, Lovelace Biomedical has designed and executed GLP and non-GLP toxicology programs — from first dose-range finding study through IND-, NDA-, and BLA-enabling submission packages — with toxicology, pathology, safety pharmacology, and bioanalysis under one roof.
Why Sponsors Choose Lovelace
One site, one team, one continuous data story.
Most safety programs lose time at the handoffs — between the in-life facility, the pathology lab, and the bioanalytical vendor. Our toxicology, clinical and anatomic pathology, genetic toxicology, and regulated bioanalytical groups sit on the same Albuquerque campus and work to the same study plan, so dose, exposure, and finding stay connected from protocol to final report.
- Non-GLP investigational tox through pivotal GLP
- Study directors with over half the team at Ph.D. level
- Standard and non-standard routes of administration
- In-house histopathology, IHC, and morphometry
- Integrated TK and regulated bioanalysis
- Not-for-profit: beholden to the science, not shareholders
Regulated bioanalytical laboratory
Toxicology Services
Capabilities you can take individually — or as one program.
Draw on a single study to answer a specific question, or build a complete safety package sequenced against your regulatory milestones. Every engagement is run by a named study director from protocol through final report.
General Toxicology
Acute, subacute, subchronic, and chronic studies in rodent and non-rodent species under GLP or non-GLP guidelines, designed around your dose-selection and submission decisions.
Dose-Range Finding & MTD
Fast, flexible non-GLP investigational studies that establish tolerability, define the dose range, and de-risk the pivotal GLP work that follows.
Safety Pharmacology
Full spectrum of core-battery and follow-up endpoints, including implanted telemetry for heart rate, blood pressure, and ECG in conscious animals.
Pathology & Clinical Pathology
Board-certified veterinary pathology (DACVP) with full histopathology, immunohistochemistry, and morphometric capability, plus serum chemistry and hematology.
Toxicokinetics & Bioanalysis
In-house method development, method transfer, and sample analysis — including dosimetry and tissue-specific compound analysis — connecting exposure to observed effect.
Specialty & Non‑Standard Routes
Beyond IV and PO: intra-arterial, intrathecal, intracerebral, intraventricular, nasogastric, continuous infusion, and industry-leading inhalation, intratracheal, and intranasal delivery.
Regulatory Strategy & Reporting
IND-, NDA-, and BLA-enabling program design with SEND-compliant datasets and submission-ready reports for FDA, EMA, and other national authorities.
Study Types by Program Stage
Match the study to the decision in front of you.
A comparison-ready view of what we run, when it typically fits, and what it produces — useful when you are scoping a program or evaluating providers side by side.
Scroll the table sideways to see all columns
| Study type | Typical stage | Compliance | Primary output |
|---|---|---|---|
| Dose-range finding / MTD | Candidate selection | Non-GLP | Tolerated dose range, dose selection for pivotal work |
| Acute & subacute toxicity | Early safety | GLP or non-GLP | Single- and short-repeat-dose safety profile |
| Subchronic toxicity (e.g. 28 / 90-day) | IND-enabling | GLP | NOAEL, target-organ findings, TK exposure |
| Chronic toxicity | NDA / BLA-enabling | GLP | Long-term safety margin and cumulative effects |
| Genetic toxicology(by third party - collaboration) | IND-enabling | GLP | Genotoxic potential for the submission package |
| Safety pharmacology (incl. telemetry) | IND-enabling | GLP | Cardiovascular, respiratory, and CNS function |
| Toxicokinetics & biodistribution | All stages | GLP or non-GLP | Systemic and tissue-level exposure tied to findings |
Study designs are tailored to your molecule and target indication. Stage guidance above is typical, not prescriptive — we will tell you plainly if a study is not yet worth running.
How We Work
From scientific question to submission-ready package.
We start with your molecule, its intended clinical route, and the regulatory milestone you are working toward — then build the shortest credible path to a defensible answer.
Scope the question
Define species, route, dose range, endpoints, and the decision each study has to support.
Design for the agency
Protocols written to FDA, EMA, and OECD expectations, reviewed by your team before first dose.
Execute under one plan
In-life, clinical pathology, histopathology, and bioanalysis run on the same campus and timeline.
Interpret and submit
Integrated reports, SEND-compliant datasets, and direct scientist access for agency questions.
Species, Routes & Endpoints
Right model. Right route. Right endpoints.
We match study design to the biology of your therapeutic and the expectations of your reviewing agency, across the full range of laboratory species and dosing methods.
Species & Models
- Mouse, rat, hamster, guinea pig
- Rabbit, ferret
- Canine
- Göttingen, Sinclair, Yucatan, and Yorkshire swine
- Sheep
- Non-human primate
Routes of Administration
- Standard: IV, IM, IP, SC, PO, dermal
- Infusion: bolus, intermittent, continuous
- Inhalation: nose-only, head-only, whole body
- Intratracheal, intranasal, nasogastric
- Arterial: hepatic, carotid, femoral
- Intracerebral, intraventricular, intrathecal
Endpoints & Assays
- Serum chemistry and hematology
- Clinical and anatomic histopathology
- Telemetry: HR, BP, ECG
- Serum and tissue-based biomarkers
- PK / TK and biodistribution
- Immunotoxicity and biomarkers
- Imaging: radiography, SPECT, MRI / fMRI
Modalities Supported
- Small molecules
- Biologics: antibodies, proteins, peptides
- Oligonucleotides (ASOs), siRNA, and other nucleic-acid therapies
- Antibody-drug conjugates
- Gene therapy and cell therapy programs
Inside the Facility
Every study activity under one roof, on one Albuquerque campus.
"Our toxicology, bioanalytical, pathology and genetic toxicology capabilities are combined in a centralized facility, allowing us to efficiently conduct an array of IND-enabling studies."
An independent, not-for-profit CRO with an extensive record of designing and executing regulatory toxicology studies for submission to U.S. and European authorities, including FDA and EMA, with the capability to address other national requirements as well.
In-house anatomic pathology
Frequently Asked
Questions sponsors ask before the first study.
Bring us your safety question.
Send us the molecule, the route, and the milestone. A study director will come back with a feasible design, a realistic timeline, and an honest view of what the data will and will not tell you.