In vivo Analyses Flashcards
What is observed during in vivo testing?
cytotoxicity sensitization system toxicity (acute) chronic toxicity implantation hemocompatibility carcinogenicity reproductive and developmental toxicity biodegradation immune-response
What is sensitization?
estimating potential adverse effects from contact with material, or extracts with material
must consider effects leachable
test various contact times (hours to months)
cutaneous (skin contact)
mucous membrane (oral tissue)
subcutaneous (intradermal transplantation)
assessing signs in inflammation
What is the difference between chronic and acute system toxicity tests?
Acute: gives an estimate of potential harmful effects of single and multiple exposures during a 24hr period
Chronic: major lifespan of animal
What is considered for hemocompatibility?
hemomorphology hemolysis clotting complement activation platelet and leukocyte count thrombosis (clotting) looking health and behavior of the blood
What does implantation test?
Assesses the local pathological effects on living tissue
gross and microscopic level
sample of material is surgically implanted in appropriate site based on intended application
Short term (12 weeks) vs. long term (1-2) years
Assess tissue response at 1 and 4 weeks
What does carcinogenicity test?
Tumorigenic potential
carried out over major portion of animal lifespan (at least two years)
only needed if data from other sources suggest carcinogenicity is an issue
done in random with implantation
What does reproductive and developemental toxicity asses?
only needs to be conducted if the device has potential impact on the reproductive potential of subject
teratogenicity (prenatal and early post natal development)
Looks at the offspring rather than the mother
When are in vivo test performed?
Only when a new material is designed, production method, how does it degrade
very costly, and lots of time needed
