Non-clinical Local Tolerance Studies
Local tolerance testing is a one of the key elements in both non-clinical and clinical drug safety evaluation. The evaluation of local tolerance should be performed in the laboratory experiments prior to human exposure to the product. The purpose of these studies is to ascertain whether medicinal products (both active substances and excipients) are tolerated at the sites in the body.
Tolerance should be determined at those sites that come into immediate contact with the medicinal product as a result of the method of administration. This should be taken place before the first trials in humans with any formulation. In addition, for those sites that might come into contact through accidental or unavoidable exposure to the product, a pre-clinical evaluation for local tolerance should be conducted before clinical trials. It is worth to notice that the site of administration can be the same organ or tissue which is intended to be the therapeutic target, or the site of administration can be remote from the intended therapeutic target. Therefore, sometimes, non-clinical local tolerance for several organs will be tested for a single drug candidate.
Creative Animodel provides comprehensive local tolerance testing and a number of animal species can be used for this study, the most commonly used species are rats, mice, dogs and rabbits. Our local tolerance studies are applicable to all types of drug products, including biotechnology-derived pharmaceuticals, chemicals and herbal products.
Testing’s for particular routes of administration：
✓ Ocular Tolerance Testing
✓ Dermal Tolerance Testing
✓ Transdermal Systems
✓ Parenteral Tolerance Testing
✓ Rectal Tolerance Testing
✓ Vaginal Tolerance Testing
Our local tolerance studies in animal models can be performed as a stand-alone experiment, or be part of other toxicity studies provided the medicinal product is administered under adequate conditions. It is recommended that the local tolerance testing should if possible be part of other toxicity studies in order to reduce the number of animals as much as possible. With the expertise in this area for years, Creative Animodel will be your best partner in your drug safety assessment.
✓ Personalized study design to meet unique needs of the sponsor
✓ Highly experienced scientific staff with state-of the-art technology
✓ Technical advisory and support regarding interpretation of study results
✓ Study designs based on the most up-to-date guidelines