local tolerance

Local Tolerance

Regulatory requirements demand that local tolerance to the test item must be evaluated 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 that may come into contact with the product as a result of its administration in clinical use. The administration site may be the same organ or tissue as the intended therapeutic target (e.g. the skin for externally administered dermatological products, the eye for ophthalmic medicinal products), or by contrast, the administration site may be remote from the intended therapeutic target (e.g. intravenously administered medicinal products).

Vivotecnia provides local tolerance assessment as part of general toxicity studies provided that the medicinal product is administered under suitable conditions in addition to offering testing procedures for specific administration routes:

 

  • Ocular tolerance testing
  • Dermal tolerance testing
  • Transdermal systems
  • Parenteral tolerance testing
  • Rectal tolerance testing
  • Vaginal tolerance testing
  • Buccal tolerance testing
  • Sensitizing potential
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Methodology
  • Guideline on non-clinical local tolerance testing of medicinal products, EMA/CHMP/SWP/2145/2000 Rev. 1, Corr. 1
  • Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, ICH M3(R2), June 2009
  • Preclinical safety evaluation of biotechnology-derived pharmaceuticals, ICH S6(R1), June 2011
  • Nonclinical evaluation for anticancer pharmaceuticals, ICH S9, October 2009

 

Equipment and facilities
Ocular tolerance testing

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

  • Intravitreal injections
  • Esthesiometry
  • Tonometry
  • Pupillometry 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 local tolerance toxicity tests and GLP-compliant general toxicity studies. Our state-of-the-art facilities, equipment, and expertise make us your trusted partner for conducting dermal procedures.

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

CONTACT

For more information or a formal quotation, please send us a message and we will contact you as soon as possible.



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