Nucro-Technics offers a broad array of in vivo toxicology services that cover a wide range of OECD GLP, FDA GLP, and GMP regulatory guidances and methods using both rodent and non-rodent species. Being a Contract Research Organization (CRO) for more than 50 years, Nucro-Technics is not limited to having expertise in a specific product class or for a particular therapeutic indication.
NUCRO-TECHNICS CAN MEET YOUR PROOF OF CONCEPT, IND-ENABLING, CHEMICAL, MEDICAL DEVICE, SAFETY TESTING, AND BIOASSAY NEEDS
IND-enabling studies conducted in Nucro-Technics’ Toxicology laboratory are compliant with Good Laboratory Practices (GLP) as defined by the OECD and the FDA. The organization has been accredited by the Standards Council of Canada and the Nucro-Technics facility is in compliance with AAALAC, the CCAC, and the Animals for Research Act (Ontario). All IND-enabling studies at Nucro-Technics are captured using validated software. Along with the pivotal safety study and safety pharmacology reports, raw data from all studies and can be exported to the SEND format for electronic submission to the FDA.
Bioassays run at Nucro-Technics are compliant with Good Manufacturing Practices (GMP) regulations as defined by the FDA, Health Canada, and the European Medicines Association. These studies are used to support the release of finished drug product to the market or to justify the use of a lot of raw material in a product formulation and are run in accordance with the USP, European Pharmacopoeia (EP), British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP).
Nucro-Technics’ toxicology group is supported by in-house Bioanalytical, Clinical Pathology, and Histopathology services.
In Vivo Models & Routes of Administration
Nucro-Technics’ study capabilities are inclusive of the following animal models:
- Rat;
- Mouse;
- Rabbit;
- Hamster;
- Guinea pig;
- Dog;
- Minipig
The following routes of administration are routinely used for both GLP and Non-GLP in vivo studies conducted at Nucro-Technics:
- Oral
- Intravenous (bolus and infusion)
- Dermal
- Subcutaneous
- Intramuscular
- Intraperitoneal
- Ocular
- Intradermal
MOST COMMON SERVICE OFFERINGS FOR GMP & GLP-COMPLIANT TOXICOLOGY TESTING
| Service Offering | Service Details |
|---|---|
| Pharmacokinetic / Toxicokinetic Studies |
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| ADME Studies |
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| Acute Toxicity Studies |
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| Subacute Toxicity Studies |
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| Subchronic Toxicity Studies |
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| Chronic Toxicity Studies |
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| Safety Pharmacology Studies |
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| Bioassay Studies |
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| Carcinogenicity Studies |
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| Efficacy Studies |
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| Veterinary Drug Testing |
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| Clinical Pathology Services |
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| Immunoassays |
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| Histopathology Services (Pathology) |
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| Support Services |
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