Safety & Toxicology

Streamlining your development process

Safety & Toxicology

SOT Experimur Annoucment YouTube Channel Art 3 - Safety & Toxicology

 

Frontage Laboratories provide safety assessment and toxicology services to guide new therapies from discovery through development to product launch. Our highly skilled and client-focused staff has extensive academic, scientific, and pharmaceutical industry experience. Our studies are conducted in laboratories and suites specifically designed to facilitate a wide range of test species (rodents to primates) and administration routes and are equipped with state-of-the-art instrumentation.

drug safety fact sht r1 - Safety & Toxicology

We offer a complete suite of services including Pivotal and Genetic Toxicology, General Toxicology, Toxicokinetic studies, and Safety Pharmacology. 

Our extensive profile of IND-enabling pivotal studies to support the swift progression of your lead compounds into the clinic – streamlining your development process. 

IND-Enabling Studies

  • Regulatory/General Toxicity
    • Maximum tolerated dose
    • Dose range-finding – 5-14 days
    • Single and repeat-dose GLP
    • Rodents, dogs, NHP, minipig
    • Complete toxicokinetic support with LC-MS/MS
  • Safety Pharmacology
    • ICH core battery: CV, CNS, respiratory
    • Supplemental studies: renal, GI
  • Full clinical and anatomic pathology, ophthalmology, ECG
  • SEND

With Experimur’s acquisition, Frontage now has significantly expanded our range of services, supporting customers’ drug-development programs beyond IND and into NDA-enabling toxicology studies. 

SOT graphic - Safety & Toxicology

Specialized Toxicology 

  • DART 
    • Embryo-Fetal Development (EFD) Studies in Rats and Rabbits
    • Fertility and Early Embryonic Development (FEED) Studies in Rats
    • Pre- and Postnatal Development (PPND) Studies in Rats
    • Single and Multi-generation studies in Rats
    • Sperm Analysis/Vaginal Cytology
  • Juvenile Toxicity studies in Rats and Dogs
  • Infant Nutrition Studies in Pigs and Rats
  • Chronic Toxicity Studies
  • Investigative Toxicology Studies
  • Neurotoxicity Studies in Rats
  • Carcinogenicity Studies in Rats and Mice (including transgenic) 

Experimur/Frontage, Chicago, IL

Frontage, Concord, OH

Frontage, Suzhou, China

Facility

Custom-designed, purpose-built, 54,000 sq ft Custom-designed, purpose-built, 85,000 sq ft >200,000 sq ft

IND-Enabling Services

Dose Formulation

General Toxicology

  • Subchronic
  • Chronic

Safety Pharmacology

  • Cardio
  • Respiratory
  • Neuro
General Toxicology

  • Maximum tolerated dose
  • Dose range-finding – 5-14 days
  • Single and repeat-dose GLP
  • Rodents, dogs, NHP, minipig
  • Toxicokinetics

Safety Pharmacology

  • ICH core battery: CV, CNS, respiratory
  • Supplemental studies: renal, GI

Full clinical and anatomic pathology, ophthalmology, ECG

SEND

Dose Range Finding Test

Single-dose & Repeated-dose Toxicity Testing

Genotoxicity

Safety Pharmacology

  • ICH Core Battery: CV, CNS, Respiratory

Local Toxicity Testing

Immunogenicity Testing

Toxicokinetics (TK)

NDA-Enabling Services

Specialized Toxicology

Animal Rooms

40 Animal Rooms (23 small, 17 large) 32 Animal Rooms 100 Animal Rooms

In-house Histology and Pathology

Yes Yes Yes

Accreditations

  • AALAC-Accredited
  • USDA-Registered
  • OLAW-Assured
  • GLP-Compliant Operations
  • DEA licenses Schedule 1-5
  • AALAC-Accredited
  • USDA-Registered
  • OLAW-Assured
  • GLP-Compliant Operations
  • DEA licenses Schedule 2-5

Additional in-house support services include histology, diagnostic pathology, clinical pathology, and analytical chemistry.

GLP Analytical Support

  • Dose formulation analysis method development, validation, sample analysis under GLP
  • Bioanalytical method development, validation, sample analysis under GLP, plus pharmacokinetics determination

Animal Welfare

Frontage Laboratories, Inc. is committed to the enhancement of animal health and welfare. We honor an organizational commitment toward the ethical and humane use of laboratory animals, paying particular attention to the housing conditions and environmental enrichment of our animal species.

General Toxicology

Frontage’s general toxicology group provides all of the resources you’ll need for your investigational plans.

Learn More

IND Enabling Studies

Managing an Investigational New Drug (IND) program and submission is a daunting task, requiring extensive planning and ongoing coordination of multiple scientific disciplines, each interrelated and reliant upon the other to achieve each successive milestone.

Learn More

DART

In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires initiation of preclinical developmental and reproductive toxicity (DART) studies using mammalian research models.

Learn More