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July 08, 2016

Single dose toxicity study / Extended single dose toxicity

The test item is administered in one or more doses during a period not exceeding 24 hours.

The aim of this study type to

  • choose doses for repeat-dose toxicity studies
  • provide preliminary identification of target organs of toxicity, and, occasionally, revealing delayed toxicity
  • assess dose-response relationships and toxicokinetic data,
  • aid the selection of starting doses for Phase 1 human studies
  • provide information relevant to acute overdosing in humans.

Species:

  • Mammalian species including non-rodents
  • At Aurigon a in-house historical database for a wide range of rodent and non-rodent species (Mouse, Rat, Syrian Hamster, Guinea Pig, Rabbit, Beagle Dog, Göttingen Minipig) is available

Design:

Designs are customized to test item class, test item characteristics and intended clinical use:

  • Intended clinical administration route
  • 14 days of recovery after administration
  • Specific monitoring parameters (mortalities, clinical observation, body weight, food/water consumption, ophthalmology, ECG, clinical pathology)
  • Complete necropsy (with organ weight measurement) and optional histopathology (more than 42 organs and tissues)
  • Formulation analysis if necessary (see Formulation analysis of dose formulations in toxicity studies)
  • Optional TK profiling in satellite animals in rodents
  • Optional 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, vaccines, medical devices

Special comments:

Outcome:

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

Contact: Aurigon

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

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