Midterm 1 theory Flashcards
What is the ACC oversee
Checks for good animal practice. Checks for the CCAC certification of good animal practice. Enforces the three R program
What are the 3Rs
Replacement, refinement, reduction
What does Calas do
Improves the standards of practice is enhance animal welfare. Have a national and regional chapter. Also have a registry board exam to be a certified Lab animal technician
What does calam do
Concerns veterinarians in lab animal settings
What does aaalac do
Similar to CCAC. Accreditation program in the USA. It is international although based in USA
What does aalas do
Similar to calas
What does aclam do
Similar to calam. For vets
Describe in vitro preclinical testing
In cultures
Describe in vivo preclinical testing
Preclinical testing on live animals
What is the purpose of preclinical testing
Done for safety, efficacy. Required to test on 2 species. Ie: 1 rodent, 1 rabbit
Where do you do new drug submissions in the USA
At the fda
Where are the new drug submissions done in Canada
Health Canada
What is gcp
Good clinical practice
What should the gcp do
Should be observed in the conduct of all human drug investigations
What is the first phase of the clinical trial
20-100 healthy candidates. Assesses safety and dosage
What is phase 2 of clinical trials
On larger groups 20-300. Tested on people who have the disease. Evaluate for side effects and efficacy.
What is phase 3 of the clinical trial
Multicenter trials, randomized controlled studies
What happens if phase 1-3 is successful
All data is submitted to the regulatory authorities (nds). Once accepted there is still a phase 4
What is phase 4 of the clinical trial
Monitoring to check for side effects
What is glp
Good laboratory practice relating to non clinical research. Instituted by fda in early 1970. Establishes safety in non clinical studies: food and color additives, drugs, medical devices, pesticides
What does the glp regulate
All the methods that must be used to conduct preclinical trials including documentation of data
What is certified food
Food is made without contaminates, then checked for metal, antibiotics
Why do we follow glp
Assure quality of research for fda.
How do you ensure glp is followed
Hire a QA unit to monitor, study, and they report to upper management.