Covance - Safety Assessment Solutions

Successfully assess the potential for genetic damage or identify genotoxic impurities in your compounds:

• Regulatory Assays
• Screening Studies (including micro-well AMES screening assay)
• Multi-Endpoint Assays

Consider some of our standard battery of tests that meet ICH or OECD requirements:

In vivo assays

• Rodent bone marrow micronucleus and chromosome aberrations
• Comet and combination (micronucleus and Comet)

Non-standard assays
Investigative assays give you a quick way to address and resolve issues with lead candidates as you move through the development journey. Tap into unique solutions such as centromere probing of micronuclei, 3D skin models, as well as in vivo comet and transgenic Muta™Mouse assays. These unique solutions enable you to gain genetic insights about your molecule – solutions that most other CROs can’t help you obtain.

Observe ability of a substance to cause local reaction and/or systemic poisoning by contact with the skin.

Why Covance for toxicology:

• The largest and most comprehensive toxicology capabilities in the industry, with 5,500+ studies initiated in the last four years

• 60% of Study Directors have 10 or more years of experience

• Best-in-class study timelines with 99% on-time reporting

Species:

• Rodent: Rat, Mouse, Rabbit, Hamster
• Non-rodent: Canine, Nonhuman Primate, Mini-pig

Duration:
Single-dose / special, Range-finding, Sub-chronic, Chronic, Carcinogenicity

Administration:
Dermal, Gavage, Implant, Intracutaneous, Intramuscular, Intranasal, Intraperitoneal, Intrathecal, Intratracheal, Intravenous, Rectal, Subcutaneous, Vaginal

Specialty Toxicology services also available, including:

• Cardiovascular studies
• Ocular toxicology
• Neurotoxicology
• Bone toxicology
• Routine toxicology studies in marmosets
• Uroflow test
• Muscle circumference (anabolic effects)
• Body composition
• Reproechocardiography
• Continuous infusion
• Geriatric models
• Specialized NHP imaging – including: MRI, CT, Ultrasound

Successfully assess the potential for genetic damage or identify genotoxic impurities in your compounds:

• Regulatory Assays
• Screening Studies (including micro-well AMES screening assay)
• Multi-Endpoint Assays

Consider some of our standard battery of tests that meet ICH or OECD requirements:

In vitro assays

• Ames, mammalian gene mutation (mouse lymphoma assay)
• Chromosome aberration (human lymphocytes and CHO cells)
• Micronucleus (human lymphocytes and cell lines)

In vivo assays

• Rodent bone marrow micronucleus and chromosome aberrations
• Comet and combination (micronucleus and Comet)

Non-standard assays
Investigative assays give you a quick way to address and resolve issues with lead candidates as you move through the development journey. Tap into unique solutions such as centromere probing of micronuclei, 3D skin models, as well as in vivo comet and transgenic Muta™Mouse assays. These unique solutions enable you to gain genetic insights about your molecule – solutions that most other CROs can’t help you obtain.

Characterize adverse effects on the immune system utilizing a variety assays and technology platforms

Characterize adverse effects on the immune system utilizing a variety of cell-based assays and technology platforms, such as:

• Natural Killer Cell Cytotoxicity Assays
• Lymphocyte Proliferation Assays
• Cytokine Analysis
• Tissue Cross-Reactivity
• ELISA and other Immunochemistry Models
• ELISPOT assay
• Toxicology Assessment of Vaccines
• Neutrophil and Monocyte Function
• Platelet Function
• Flow Cytometry

Follow an integrated approach to non-GLP and GLP safety assessment with a multi-disciplinary approach and obtain your endpoints to meet regulatory requirements, uncover future issues and advance the best molecules.

• Cardiovascular Assessment
  • Digital multi-lead ECGs
  • Jacketed External Telemetry (JET™)
  • Jacketed External Telemetry with Blood Pressure (JET-BP)
  • High Definition Oscillometry (HDO)
  • High-quality ECG Analysis and Interpretation
• ICH Core Battery Tests
• ICH Supplemental Tests
• Discovery Support
• Infusion Services

Access comprehensive, state-of-the-art DART and Nonhuman DART services:

• Extensive NHP DART experience with 120+ studies in pregnant NHPs and 25+ (e)PPND studies
• Social housing is standard for NHP DART studies
• DART experience and capacity with 70+ studies conducted in small models per year

Get specialized reproductive and developmental toxicology experience to design and perform your studies effectively; innovative techniques and the capacity to enable you to meet your timelines efficiently; and regulatory know-how to ensure you meet all requirements compliantly.

• Seg I — Fertility and Early Embryonic Development
• Seg II — Embryo Fetal Development
• Seg III — Prenatal and Postnatal Development
• ePPND — Enhanced Pre- and Post-natal Development
• Juvenile Toxicity Studies
• Special Developmental and Reproductive Toxicology Studies
• Infusion Services

Animal Models and Studies Services

Pharmacology Services

Drug Discovery & Development Services