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July 09, 2016

Local tolerance testing (in vivo)

The main goal of this test:

The main goal of these studies is to evaluate the tolerability of the test item at sites in the body, which may come into contact with the product during clinical use (ocular, cutaneous, transdermal, parenteral). It can be the site of administration or a result of potential unintended/accidental administration.

Species:

  • Two species as part of other toxicity studies
  • One relevant species in a “stand-alone” study

Design:

  • It is recommended that the evaluation of local tolerance should be performed in the general toxicity studies (no “stand-alone” study)
  • Doses (concentration) and frequency and duration of treatment are based on the planned clinical use

Outcome:

The local tolerance is evaluated on the basis of the local signs and the histopathological evaluation.

Contact: Aurigon

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

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