Vivotecnia

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).