Preclinical Toxicology & Safety Pharmacology

Toxicology and safety pharmacology studies designed to identify safety signals, characterize dose and exposure relationships, and support informed development decisions.

A staged approach to preclinical safety assessment.

We coordinate early toxicity screening, general toxicology, special toxicology, toxicokinetics, and safety pharmacology through partner laboratories matched to the required study type. Species, study duration, endpoints, and quality framework are confirmed for each program.

Early workScreening, Dose-range finding
Core studiesGeneral tox, Toxicokinetics
Focused studiesSpecial tox, Safety pharmacology

Toxicology and safety study capabilities.

Early toxicity screening

In vitro or in vivo screening and dose-range-finding work to identify potential liabilities and inform subsequent study design.

General toxicology

Single- and repeat-dose toxicity studies with clinical observations, clinical pathology, organ assessment, histopathology, and toxicokinetics as required.

Special toxicology

Fit-for-purpose genotoxicity, local tolerance, immunotoxicity, reproductive or developmental, and other focused assessments where relevant.

Safety pharmacology

Assessment of potential effects on cardiovascular, respiratory, and central nervous system function using program-appropriate study designs.

Common toxicology study outputs.

Clinical observations

Mortality or morbidity checks, clinical signs, body weight, food consumption, and other protocol-defined observations.

Clinical pathology

Hematology, clinical chemistry, urinalysis, and other selected laboratory parameters.

Pathology

Organ weights, gross examination, tissue collection, and histopathology according to study scope.

Exposure & function

Toxicokinetic exposure and safety pharmacology endpoints for relevant organ systems when included.

Study design, laboratory, quality framework including GLP status, species, timelines, and deliverables are confirmed during technical review.

What must be aligned before a toxicology study.

  • Compound modality, formulation, and available characterization
  • Development stage and intended use of the study
  • Species, dose route, dose levels, and treatment duration
  • Target organs, known signals, and special safety questions
  • Toxicokinetic, pathology, and safety pharmacology endpoints
  • Required quality framework, reporting, and data deliverables

Planning a toxicology or safety study?

Share the compound, development stage, intended route, available exposure data, and safety question. We can review the appropriate study type and laboratory route.Required fields are marked with an asterisk(*).

What are you developing?
What should the study help evaluate?

Briefly describe what you are developing, what you want to evaluate, what material you have available, and any timeline or study requirements.

Your contact