local tolerance

Local Tolerance

According to the regulatory requirements, the evaluation of local tolerance to the test item should be performed in 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 sites in the body, which may come into contact with the product as a result of its administration in clinical use. The site of administration can be the same organ or tissue which is intended to be the therapeutic target (e.g the skin for externally administered dermatological products, the eye for ophthalmic medicinal products), or the site of administration can be remote from the intended therapeutic target (e.g intravenously administered medicinal products).

Vivotecnia provides services focussing on local tolerance assessment as part of general toxicity studies provided that the medicinal product is administered under adequate conditions, as well as testing procedures for particular routes of administration:

 

  • Ocular tolerance testing
  • Dermal tolerance testing
  • Transdermal systems
  • Parenteral tolerance testing
  • Rectal tolerance testing
  • Vaginal tolerance testing
  • Buccal tolerance testing
  • Sensitising potential
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Methodology
  • ICH Guideline M3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals.
  • ICH Guideline S6 (R1) – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceutical
  • ICH Guideline S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
  • EMA/CHMP/SWP/2145/2000 Rev. 1, Corr. 1* Guideline on non-clinical local tolerance testing of medicinal products
Equipment and Facilities

Ocular tolerance testing

Vivotecnia performs ocular tolerance testing for all ocular indications. Our ocular toxicity testing capabilities, supported by scientists experts in the field, including among others:

  • Intra-vitreal injections
  • Aesthesiometry,
  • Tonometry,
  • Pupilometry and electroretinography (ERG)
  • Slit-Lamp exams and Draize and McDonald-Shadduck scoring systems
  • Direct and indirect ophthalmoscopy
  • Anterior/posterior segment and fundus photography
  • Ocular tissue dissection, distribution, and PK/PD/ADME
  • Ocular histology/pathology and clinical support

Dermal tolerance testing

Vivotecnia offers dermal toxicity tests either for local tolerance and general toxicity GLP-compliant studies.  Our state-of-the-art facilities, equipment, and expertise allow us to be your trusted partner for conducting dermal procedures.

Our expert staff work within our modern animal facilities and laboratories, specifically designed to avoid the risk of cross-contamination. We have designed customized facilities for dermal toxicity studies with rodent and non-rodent models (rabbit and minipig), which in addition to the behavioral conditioning programs developed by our veterinarian staff, allow us to reduce animal handling and stress during application procedures.

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