Toxicology and Safety

SRI offers mammalian toxicology testing services, in all major species, that follow either routine or customized study designs. Our expertise spans a wide range of pharmaceutical and therapeutic agents, including anticancer drugs, anti-infectives, vaccines, antisense therapeutics, nucleosides, peptides, antibodies, and proteins. We also offer testing of genetically engineered products and medical devices, such as combination 510(k) products, using protocols designed to meet your needs.

Related Services

Standard Mammalian Toxicology

  • Acute, subchronic, and chronic toxicity

  • Dose escalation and range-finding

  • Maximum tolerated dose (MTD)

  • Definitive dose administration

  • Lifetime and carcinogenic potential

Specialized Safety Assessments

  • Irritation and sensitization

  • Local lymph node assay

  • Immunotoxicology

  • Biological product testing

  • Vaccine safety

  • Immunogenicity

  • 510(k) medical device safety evaluation

  • Safety evaluation of cell-based therapeutics

  • Medical imaging products

  • Neonatal and juvenile animal studies

  • Combination products and delivery systems

  • Learning and memory evaluations

  • Radiation studies

Pediatric Product Development

  • Neonatal and juvenile animal studies

  • Initiation of dosing at age-appropriate developmental stage

  • Routine evaluation endpoints

  • Sensorimotor central nervous system evaluations

  • Pharmaco- and toxicokinetic evaluations

Evaluation Endpoints

  • Cage-side observations

  • Body weight measurements

  • Food and water consumption

  • Ophthalmic examinations

  • Clinical pathology

  • Necropsy and organ weight measurements

  • General and specialized microscopic pathology

  • Dose verification

  • Pharmacodynamics

  • Toxicokinetic analysis

  • DNA/RNA biodistribution, persistence, integration

  • Toxicogenomics assessment

  • Immunogenecity

  • Specialized biomarkers

  • Cardiovascular evaluation

  • Neurobehavioral evaluation

  • Micronucleus evaluation

  • Toxicology interpretation

    • Overall interpretation of findings

    • Maximum tolerated dose (MTD) estimation

    • No observable adverse effect level

  • (NOAEL) estimation

  • Quality Assurance (QA) review and QA statement

 

Projects

scientist looking through a microscope
Toxicological Evaluation of Novel Ligands Program

For the National Institute of Mental Health (NIMH), SRI performs preclinical safety and pharmacokinetics studies for brain imaging agents and drugs to treat mental illnesses.

Topics: Developmental + Reproductive Toxicology Discovery ADMET and In Vitro Metabolism Drug Metabolism and Pharmacokinetics Genetic Toxicology Pharmaceutical R+D Safety Pharmacology Toxicology and Safety

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