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>>GMP/GLP-Compliant Toxicology Studies
GMP/GLP-Compliant Toxicology Studies2019-01-07T11:31:17-05:00

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 45 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 OfferingService Details
Pharmacokinetic / Toxicokinetic Studies
  • Single repeated dose PK/TK studies in all animal models offered
ADME Studies
  • Microsome hepatocyte stability
  • Metabolite profiling
  • Tissue distribution studies
  • Permeability cell-based assays
Acute Toxicity Studies
  • Acute toxicity tests (all routes)
  • Dermal and Eye Irritation Studies
  • Dermal Sensitization (multiple methods available)
  • Vaginal Irritation Studies
  • Pharmacodynamic (PD) Studies
Subacute Toxicity Studies
  • Maximum Tolerated Dose (MTD) Studies / Dose range-finding (DRF) Studies
  • 14-day and 28-day IND-enabling toxicity studies: Repeated dermal and ocular studies
Subchronic Toxicity Studies
  • 90-day IND-enabling toxicity studies
Chronic Toxicity Studies
  • 6, 12, 18, and 24-month toxicity studies in rodents and non-rodent species)
Safety Pharmacology Studies
  • Cardiopulmonary Safety Evaluation in Dogs
  • CNS Safety Pharmacology in Rats
Bioassay Studies
  • Pyrogen
  • Human Chorionic Gonadotropin (HCG)
  • General Safety
  • Pregnant Mare Serum Gonadotropin
Carcinogenicity Studies
  • 2-year Assessment of Carcinogenicity in rats
  • Assessment of Carcinogenicity in p53 +/- mice
Efficacy Studies
  • Inflammation model rats, mice, dogs
  • Xenograft modeling using different tumor cell lines
Veterinary Drug Testing
  • Target animal safety
  • Bioequivalence
Clinical Pathology Services
  • Clinical Chemistry
  • Coagulation Tests (Hemostasis)
  • Haematology
  • Parasitology
  • Urinalysis
  • Cytology
Immunoassays
  • ELISA (Enzyme-linked Immunosorbent Assay)
  • Radial Diffusion Assays
  • Activity Assays
Histopathology Services (Pathology)
  • Histology (Grossing, Processing, Embedding, and Sectioning)
  • Paraffin Services
  • Microtomy
  • Staining
  • Immunohistochemistry
  • Microscopy
  • Photography
Support Services
  • Toxicokinetic and Pharmacokinetic Statistical Analysis
  • Bioanalytical Chemistry Sample Analysis for Drug Concentration and Dose Formulation

Let’s Work Together
For further information about these services, a complete list of services available, to receive a quotation, schedule a test, or if there is something specific that you require, get in touch.