+ Phase-I-support-Toxicology

General Toxicology

Quality studies in rodent and non-rodent species delivered on time to meet your product and international regulatory needs. Here at Sequani, we are proud of the support we give to clients and the excellent way we manage general toxicology studies in rodent and non-rodent species. The result is quality, on-time reporting. A highly experienced team of study directors works closely with clients to ensure our work meets the needs of both product development and international regulatory standards.

introduction

We can conduct studies in all commonly used species other than primates, and by all routes other than inhalation. We regularly subcontract primate studies to other trusted laboratories we have developed very good working relationships with, ensuring that we provide the best scientific expertise within each area and the project runs smoothly.
In addition to the standard toxicology services, we offer specific expertise in the following areas:

  • Creative study design to support first-in-man packages or to address specific toxicological issues.
  • Minipig toxicology.
  • Toxicology studies in mice.
  • Toxicokinetic support.
  • Meeting challenging time-lines.
  • Highly experienced in-house toxicological pathologists.

Our study directors are highly responsive and are actively involved with their studies from inception through to report finalisation. They work closely with the on-site laboratory animal services, formulation sciences, analytical chemistry, bioanalysis, clinical pathology, biomarkers, pathology, QA and information technology teams to ensure that we provide our clients with high quality studies and reports, whatever the type.
We are proud of our reputation for meeting, or beating reporting dates, even against the most difficult target times. Team members always provide good practical scientific input into the study design and reporting but also have the ability to contribute a more specialised scientific content where required.

Study Types

  • Pharmacokinetics/toxicokinetics
  • MTD and dose range-finding
  • Single Dose Toxicity
    • extended single dose studies – ICH M3 (R2)
  • Repeat Dose Toxicity
    • Short-term (7-, 14-, 28-day) studies
    • 3-, 6-, 9- and 12-month studies
  • Investigative studies
    • Bespoke study designs to investigate specific toxicological issues

Dosing Routes

  • Oral gavage
  • Oral dietary
  • Oral capsule
  • Intravenous – bolus or short-term infusion
  • Peri-vascular
  • Subcutaneous
  • Intramuscular
  • Intranasal
  • Intra-ocular
  • Dermal
  • Intradermal
  • Osmotic pumps

Species

  • Rat
  • Mouse
  • Rabbit
  • Dog
  • Minipig
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