Pharmaceutical Development

At NUVISAN, we ensure that each study closely meets the requirements of international standards so that the data generated can support your investigator's brochure and, ultimately, your marketing authorization dossier. Pharmaceutical development often requires specifically tailored study designs. With decades of experience, we can be your partner in developing protocols to generate reliable safety data for your candidate from non-GLP and pivotal GLP studies.

General Toxicology Studies

General toxicology studies are offered to support your preclinical development and are essential to IND-enabling programs. Systemic toxicity studies can always be tailored to your project, compound, and target and will include the necessary end points that will lead your project to success. We offer safety packages or single studies as non-GLP or GLP studies to add value to your preclinical development project.

Our toxicology team acts as an extension of your development team and supports you with deep toxicology knowledge and years of experience conducting in vivo studies. We build trust through providing quality. Our services include:

  • toxicokinetic evaluation after single-dose administration in rodents
  • two to four weeks DRF studies in rodents (maximum tolerated dose)
  • pivotal repeated-dose toxicity studies in rodents and non-rodents (4, 13, and 26 (39) weeks)

Administration Routes

Substances can be administered

  • orally (po, gavage)
  • via diet or drinking water
  • subcutaneously (sc)
  • intravenously (iv)
  • as an infusion
  • intra-nasally

Depending on your compound, the study directors will carefully plan an experimental protocol. Please reach out to us for inquiries on other administration methods or specific end points.

All data can be provided in SEND format.

Our non-GLP services help set-up your regulatory studies and identify doses and a maximum tolerated dose. Our pivotal GLP systemic toxicity studies prepare and support your phase I and phase II clinical trials with the necessary and reliable safety data.

Specific Toxicology Testing

In addition to our standard end points, systemic toxicity studies can be complemented with a large range of GLP and non-GLP end points and biomarkers in collaboration with our internal experts and partners from our external network. Accordingly, we offer mechanistic toxicity studies, which are closely monitored and guided by a toxicologist and a team of experts.

Species

  • Rodents: rat, mouse
  • Non-rodent: mini pig
  • Toxicity studies in other non-rodent species via strategic partnerships

Investigations

  • Clinical observations, including
    • functional observational battery
    • motor activity
    • ophthalmology
  • Clinical pathology (clinical chemistry, hemostasis, hematology, immunotoxicology)
  • Toxicokinetics
  • Toxicological pathology (necropsy and histopathology)
  • In vivo genotoxicity testing, to be integrated with general toxicity studies in rodents, such as:
    • mammalian erythrocyte micronucleus test
    • in vivo mammalian alkaline comet assay
    • mammalian erythrocyte pig-a gene mutation assay [coming soon]