Preclinical Toxicology Lab Services Overview

Nucro-Technics provides in vivo and in vitro nonclinical / preclinical toxicology testing lab services under both GLP and non-GLP conditions for the safety assessment of pharmaceuticals products, vaccines, medical devices, chemicals, natural health products / botanicals, and pesticides.  Studies performed by Nucro-Technics’ preclinical toxicology lab are designed to evaluate the potential toxicity and safety of test substances across a range of parameters.  They are submitted for regulatory review to agencies like the FDA and Health Canada which would then support the approval of Investigation New Drug (IND) applications and enable progression into clinical trials.

With over 50 years of experience, Nucro-Technics supports clients from early-stage research through to regulatory approval. We are well positioned to support clients’ Investigational New Drug (IND) Application, Biocompatibility (ISO 10993), Generally Recognized as Safe (GRAS) determinations and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) testing services. Our knowledge and decades of expertise allow us to support both routine and more novel toxicology testing programs.

What Types of Studies are Performed

The types of services offered at Nucro-Technics’ preclinical toxicology lab are very broad but can broadly be categorized in a number of different ways.

  • Microsome hepatocyte stability
  • Metabolite profiling
  • Tissue distribution studies
  • Permeability cell-based assays

PK / TK Studies

  • Single dose PK / TK studies in rodent & non-rodent models
  • Repeated dose PK / TK studies in rodent & non-rodent models

Acute Toxicity Studies

  • Acute toxicity tests
  • Dermal & Eye Irritation Studies
  • Dermal Sensitization
  • 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

Subchronic & Chronic Toxicity Studies

  • 90-day IND-enabling toxicity studies
  • 6-month, 12-month, 18-month, and 24-month toxicity studies in rodent and non-rodent species
  • Cardiopulmonary Safety Evaluation
  • CNS Safety Pharmacology

What Models and Routes of Administration are Offered?

Nucro-Technics’ preclinical toxicology laboratory offers a wide array of rodent and non-rodent animal models that are typical for an IND-development program.  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
  • Implant
  • Intramuscular
  • Intraperitoneal
  • Ocular
  • Intradermal
  • Nasal Instillation

Why Conduct your Preclinical Toxicology Program at Nucro-Technics?

Well-designed and well-executed preclinical toxicology studies performed by a competent lab are critical to the success of any drug development program. These studies provide the data necessary to evaluate the safety of new compounds and support regulatory submissions globally.

Nucro-Technics operates under OECD GLP guidelines, and the high-quality safety data generated enables global submission to agencies such as Health Canada, the US FDA, TGA, EMA, and other international regulatory bodies. Nucro-Technics is fully accredited to perform both GLP preclinical and GMP release testing. Our integrated facility houses in-house capabilities in bioanalysis, genetic toxicology, preclinical toxicology, analytical chemistry, and microbiology.

We take a consultative approach, working closely with our clients to deliver high-quality, responsive service that aligns with regulatory expectations and project timelines.

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.