What is Local Toxicity Evaluation?

Local toxicity refers to the direct damage caused by certain drugs at the contact site of the body, which initially manifests as cell death at the direct contact site. Dosage forms such as ointments, drops, lotions, scalp patches, sprays, and topical powders generally require local toxicity testing of the drug. Factors causing local toxicity include:

  • Pharmaceutical active ingredients or components
  • New ingredients produced after compatibility
  • Metabolites in the body
  • Impurities during preparation
  • Physical and chemical properties of preparations

How is Local Toxicity Evaluation Performed?

Animal Species Drug Types Administration Routes Study Content
  • Mice
  • Rats
  • Guinea
  • Pigs
  • Rabbits
  • Beagles
  • Others
  • Small molecules
  • Biomolecules
  • Natural products
  • Vaccines
  • Others
  • Gavage
  • Intraperitoneal injection
  • Intravenous injection
  • Intramuscular injection
  • Intradermal injection
  • Subcutaneous injection
  • Nasal cavity
  • Rectum
  • Vagina
  • Others
  • Hemolysis: refers to reactions such as hemolysis and red blood cell aggregation caused by drug preparations.
  • Allergy: refers to a specific immune response that manifests as tissue damage or physiological dysfunction after the body is re-stimulated by the same antigen. It is an abnormal or pathological immune response.
  • Irritation: refers to the reversible inflammatory response to the administration site after administration of parenteral preparations.
 
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