Pre-clinical trials Flashcards
What important factors need to be considered in formulation?
Bioequivalence
Bioavailability
Ease of use?
What is philosophy?
A study of the processes governing thought and
conduct.
– A system of principles for the conduct of life.
– A study of human moral
What does Descartes (1596 – 1650) suggest?
Descartes agreed with Aristotle that only humans
could be rational
What did Kant (1724 – 1804) suggest?
The ends do not justify the means”
What did Jeremy Bentham (1748-1832) suggest?
The question is not can they reason, but can they
suffer? e.g humans, dragonflies are capable of
focusing their attention
What is Utilitarianism?
Principle of Equality
Principle of Utility
All beings have rights including animals
What are the different levels of testing?
Biochemical
Isolated tissue
Whole animal testing
It is insufficient to to use doses which are not toxic; the doses
producing toxic effects and the nature of these effects MUST
be established. True or false?
TRUE
What are some objections to animal testing?
e. g poliomeylitis is monkeys
e. g USA – PETA and Edward Taub - using monkeys to break spinal cord for treatment of spinal cord injuries
What are the three R’s and describe them?
1.Reduce - the number of animals used to a minimum e.g use GM animals
2.Refine - the way experiments are carried out, to
make sure animals suffer as little as possible. e.g LD50 testing and recent alternatives
3.Replace - animal experiments with non-animal
techniques wherever possible. e.g non-invasive tests for pyrogens. Based on white blood cell
experiments, and can be done in a test-tube.
Why is it likely that animal testing will be increasing?
1.A greater volume of research
2.More targets being identified for drug therapy
3.A focus on the genetic capability of humans and
animals and possibly gene therapy technologies
