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In vivo toxicology and safety pharmacology

Safety testing in vitro and in vivo

At Nuvisan, we are committed to providing thorough and reliable in vivo toxicology and safety pharmacology testing services to characterise the safety profile of test items. Whether you need in vitro assays or in vivo studies, our experienced team is ready to support the development process of new drugs and chemicals, helping ensure your products meet global safety standards.

While Nuvisan does not offer in vivo toxicology and safety pharmacology studies directly, we assist with study design, monitoring and data interpretation, leveraging decades of hands-on experience in both areas. These studies provide valuable data for regulatory submissions and the design and initiation of first-in-human trials.   

Close-up of a syringe poised to draw liquid from a nearby sterile vial, highlighting the precision of the medical equipment.

Safety pharmacology testing in vitro and in vivo

Pharmacological safety is essential to help ensure your product does not cause harmful effects in humans. Comprehensive in vitro and in vivo testing provides critical information about how your product interacts with vital biological systems.  

In vitro assays: 

  • Cardiovascular safety (ICH TGL S7B): Assess the effects of your product on key cardiac ion channels using human-derived cells. This includes ion channel screenings (hERG, NaV1.5, CaV1.2) performed with automated patch clamp robots or corresponding regulatory GLP studies conducted manually.

In vivo assays (ICH S7A):

  • Cardiovascular safety: Evaluate the impact of your product on heart rate, blood pressure, electrocardiogram (ECG) changes and other cardiovascular functions in animal models. 
  • CNS toxicity: Assess the potential neurotoxic effects of your product in vivo, including behavioural assessments, sedation, convulsions and other CNS-related outcomes (Modified Irwin Study).  
  • Respiratory function testing: Measure the effects on respiratory rates, lung function and airway response in animal models exposed to your product.

These essential studies help you ensure the safety and efficacy of your product, providing valuable data for regulatory submissions and guiding the development process.

 

In vivo toxicology testing

In vivo toxicology testing is a critical step in characterising the safety of your potential products, particularly for long-term use or exposure to vulnerable populations. Our non-GLP studies are ideal for early-stage safety assessments and screening, while GLP-compliant studies ensure that your new drug or chemical meets stringent regulatory requirements. By testing in both rodent and non-rodent species, you gain the necessary data to move forward with confidence.   

Non-GLP studies (screening studies):  

  • Acute toxicity: Assess the potential lethal or harmful effects of a single exposure to your test item in rodents and non-rodent species. Different administration routes, ranging from oral to dermal exposure, can be conducted to evaluate the immediate impact of your test item.  
  • Subchronic toxicity: Evaluate the effects of repeated exposure over a short-term period (2 to 4 weeks) to understand potential risks from prolonged use.

GLP-compliant studies (regulatory studies):

  • Chronic toxicity studies: Long-term studies (13 weeks or more) to evaluate the potential adverse effects of chronic exposure to your test item
  • Carcinogenicity testing: In-depth studies to assess the potential cancer-causing effects of long-term exposure, using rodent models that can provide reliable, regulatory-compliant data  
  • Reproductive and developmental toxicity: Studies designed to evaluate the impact of your test item on fertility, reproductive health and developmental processes in rodent and non-rodent species.
  • Immunotoxicity testing: Evaluate the potential effects of your test item on the immune system, identifying any risks that could impact immune function or lead to adverse immune responses. 

These essential studies help ensure the safety and efficacy of your product, providing valuable data for regulatory submissions and guiding the development process.

 

 
 
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