2 Animal Models And Pharmacological Testing Flashcards
What happened in:
1. 1933
2. 1937
3. 1938
1933 - lash lure mascara causing blindness
1937 - mass poising in USA from sulfanilamide in diethylene glycol dilutent
1938 - mandatory testing on animals before release
Main element of animal testing
Toxicity
Non-toxic to mice, toxic to humans example
Fialuridine (FIAU) – hepatitis medication in phase II trials
Hepatic damage; mortality and moribidity
Did not have any deleterious effects in mouse model. Impacted mitochondria in humans; mouse transporter worked differently so mice unaffected
Clinical trials phases
Preclinical
Phase 1
Phase 2
Phase 3
Treatment put forward for approval
Preclinical testing
Exploring if a new drug may work
Phase 1
Drug approved for testing in humans
Small numbers of patients
Studying the safety of the drug in humans and maximum safe dose
Phase 2
Up to 300 patients
Further safety study - exploring effectiveness of treatment and identification of any side effects
Phase 3
100-1000 patients
Further explore the safety and effectiveness
Study to measure effectiveness against current standard treatments
Monitor side effects
What are the advatages of the use of in silico and in vitro human alternatives
Predict responses of reaction in humans
Physiology
Both cellular and organismal are complex phenotypes that can vary amongst species
Advantages of animal testing
Disadvantages of animal testing