Moving client compounds swiftly into human studies and onto the market

Toxicology Services

Moving client compounds swiftly into human studies and onto the market

Frontage’s toxicology business unit provides an array of services for investigational purposes, or IND, support. Typically, GLP toxicology, GLP toxicity studies, and pivotal toxicity studies are performed in two species for durations of 14 or 28 days, and often include translational biomarkers or investigational endpoints that assist with compound development. Toxicity studies are complemented by safety pharmacology studies, commonly conducted simultaneously to expedite development. All standard dosing regimens and species are supported, including primates, and our GLP tox studies are conducted in strict compliance with GLP regulations. Our GLP toxicology studies have supported hundreds of successful client IND submissions.

Pivotal Toxicology

You will find Frontage is outstanding at performing pivotal biosciences research. We offer pivotal toxicology studies for safety toxicity and toxicity evaluation of candidate compounds. Our toxicological studies are conducted on a variety of animal models, ranging from IND-enabling to smaller tox studies,  and provide a basis for identifying hazards and conducting safety assessments that support IND filing and support use in humans. Our IND-enabling toxicology is performed by experienced scientists who can recommend appropriate study parameters and protocol elements, enabling the collection of a robust and comprehensive data package for IND submission. We offer comprehensive expertise to execute your IND study needs with services optimized to meet the most aggressive execution timelines.

Non–Rodent Toxicology Services

General Toxicology

  • Acute to chronic studies (Single dose to 1 year)
  • Dermal studies

Routes of Administration

  • Oral
    –Gavage
    –Capsules, tablets, pills
  • Intravenous
    –Bolus injection
    –Infusion
  • Subcutaneous injection
  • Intramuscular injection
  • Intraperitoneal injection
  • Dermal application
  • Intranasal

ADME

  • Pharmacokinetic studies
  • Excretion mass balance
  • Tissue distribution

Rodent Toxicology Services

General Toxicology

  • Acute to chronic toxicology studies
  • Two year carcinogenicity studies

Routes of Administration

  • Oral Gavage
  • Dietary admixture
  • Intravenous
    –Bolus injection
    –Infusion
  • Subcutaneous injection
  • Intramuscular injection
  • Dermal application
  • Intraperitoneal injection

ADME

  • Pharmacokinetic studies
  • Excretion mass balance
  • Tissue distribution

Safety Pharmacology Services

  • Core services
    –Respiratory function
    –CNS
    Motor activity
    FOB
  • Supplemental studies
    –Gastrointestinal tract
    –Renal function