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July 08, 2016

Repeated dose toxicity studies

The main goals are to

  • identify the toxicological targets,
  • characterize the toxicological profile of the substance,
  • define the NOAEL,
  • assess the MTD,
  • define the dose, plasma, or tissue levels at which toxicological effects are to be observed,
  • assess the toxicokinetics,
  • understand basic mechanisms of identified toxicities.

Species:

  • Mammalian species including  non-rodents
  • In-house historical database for a wide range of rodent and non-rodent species (Mouse, Rat, Syrian Hamster, Guinea Pig, Rabbit, Beagle Dog, GöttingenMinipig)available at Aurigon

Design:

  • 14 days, 28 days, 90 days or 6/9 month duration of the treatment phase
  • Designs customized to test item class, test item characteristics and intended clinical use:
    • Duration of recovery period after treatment phase
    • Administration schedule and route
    • Specific monitoring parameters (clinical observation, body weight, food/water consumption, ophthalmology, ECG, clinical pathology)
    • Complete necropsy (with organ weight measurement) and histopathology (more than 42 organs and tissues)
    • Control group and 3 dose groups
    • Formulation analysis if necessary (see Formulation analysis of dose formulations in toxicity studies)
    • TK profiling in satellite animals with either 2 or 3 profiles in rodents
    • TK profiling in animals of main groups in non-rodents
    • Immunotoxicity screening if required
    • Standard administration routes including long term i.v. infusion available at Aurigon
    • Non-standard administration routes: intranasal, intranodular, intraspinal available at Aurigon
    • Special design for ATMPs, CBMPs, biologics, vaccines, medical devices

Special comments:

Outcome:

  • Determination of target toxicity organs
  • MTD, NOAEL
  • Dose-response relationship
  • Toxicokinetic evaluation

Contact: Aurigon

Phone: +49 (0)89 780 7200 10
E-Mail: info(at)aurigon.de

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